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The purpose of this study is to evaluate changes in exposure to selected harmful and potentially harmful constituents (HPHC) by measuring biomarkers in adult smokers who partially or completely switch from smoking cigarettes to oral tobacco-derived nicotine (OTDN) products compared to those who continue exclusive smoking cigarettes or stop using all tobacco products.
This is an open label, randomized, 6 parallel-group clinical study evaluating changes in exposure to selected HPHCs, subjective effects, and product use behavior in adult smokers relative to continued smoking who are randomly assigned to continue smoking, partially or completely switch to oral tobacco-derived nicotine products, or stop using any tobacco products for 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP 1: Continue Smoking | No Intervention | Subjects will be asked to continue smoking their own brand (OB) cigarettes ad libitum for 7 days. | |
| GROUP 2: OTDN product 1 | Experimental | Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline cigarettes per day (CPD) and use at least 3 oral tobacco-derived nicotine (OTDN) product units per day for 7 days. |
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| GROUP 3: OTDN product 2 | Experimental | Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 oral tobacco-derived nicotine (OTDN) product units per day for 7 days. |
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| GROUP 4: OTDN product 1 | Experimental | Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine (OTDN) product, using at least 3 OTDN product units per day for 7 days. |
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| GROUP 5: OTDN product 2 | Experimental | Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine (OTDN) product, using at least 3 OTDN product units per day for 7 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTDN product 1 | Other | Oral tobacco-derived nicotine product |
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| Measure | Description | Time Frame |
|---|---|---|
| Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the lower limit of quantitation (LLOQ) (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Summary of N-nitrosonornicotine (NNN) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.500 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
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Inclusion Criteria:
Exclusion Criteria:
This study will enroll healthy adult male and female (no more than 60% of either gender) self affirmed combustible cigarette smokers, 21-65 years of age
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| Name | Affiliation | Role |
|---|---|---|
| Georgios D Karles, PhD | Altria Client Services LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS Bio-Kinetic Clinical Applications, LLC | Springfield | Missouri | 65802 | United States | ||
| Inflamax - Hill Top Research |
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Subjects were required to complete a test product tolerability trial and baseline assessment over the course of 3 days prior to randomization on Day 1 of the study. A total of 213 subjects were randomized to one of the six groups in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Product Trial | Subjects were enrolled in the product trial period but discontinued from the study prior to randomization. |
| FG001 | GROUP 1: Continue Smoking | Subjects will be asked to continue smoking their OB cigarettes ad libitum for 7 days. |
| FG002 | GROUP 2: OTDN Product 1 | Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days. OTDN product 1: Oral tobacco-derived nicotine product |
| FG003 | GROUP 3: OTDN Product 2 | Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days. OTDN product 2: Oral tobacco-derived nicotine product |
| FG004 | GROUP 4: OTDN Product 1 | Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days. OTDN product 1: Oral tobacco-derived nicotine product |
| FG005 | GROUP 5: OTDN Product 2 | Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days. OTDN product 2: Oral tobacco-derived nicotine product |
| FG006 | GROUP 6: Tobacco Cessation | Subjects will completely stop all tobacco product usage for 7 days. Tobacco Cessation: Tobacco Cessation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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ITT Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Product Trial | All subjects who used a study product during the product trial period, including subjects who were discontinued from the study before randomization and subjects who were randomized to one of the six study groups. |
| BG001 | GROUP 1: Continue Smoking |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the lower limit of quantitation (LLOQ) (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT (mITT): All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ng/24 hour | Baseline (Day -1), Day 5 and Day 7 |
Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Product Trial | All subjects who used a study product during the product trial period, including subjects who were discontinued from the study before randomization and subjects who were randomized to one of the six study groups. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffery Edmiston, Functional Director Clinical Research | Altria | 8043352366 | Jeffery.S.Edmiston@altria.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: ALCS-RDS-18-04-VRV Protocol Version 1 | Mar 30, 2018 | Mar 14, 2024 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: ALCS-RDS-18-04-VRV Protocol Version 2 | May 25, 2018 | Mar 14, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 6, 2018 | Mar 14, 2024 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| GROUP 6: Tobacco Cessation | Experimental | Subjects will completely stop all tobacco product usage for 7 days. |
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| OTDN product 2 | Other | Oral tobacco-derived nicotine product |
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| Tobacco Cessation | Other | Tobacco Cessation |
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| Baseline (Day -1), Day 5 and Day 7 |
| Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of N-nitrosonornicotine (NNN) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.500 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Summary of nicotine equivalents amount excreted (mg/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) for each metabolite were set to one-half of the LLOQ for the calculation of nicotine equivalents. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Nicotine equivalents (mg/g creatinine) = nicotine equivalents (μg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of nicotine equivalents amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) for each metabolite were set to one-half of the LLOQ for the calculation of nicotine equivalents. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Nicotine equivalents (mg/g creatinine) = nicotine equivalents (μg/mL) x 100 / creatinine (mg/dL) % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 2-aminonaphthalene (2-AN) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.7 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 2-aminonaphthalene (2-AN) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.7 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 4-aminobiphenyl (4-ABP) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.5 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 4-aminobiphenyl (4-ABP) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.5 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 2-hydroxyethyl mercapturic acid (HEMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.2 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 2-hydroxyethyl mercapturic acid (HEMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.2 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 2-cyanoethylmercapturic acid (CEMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 2-cyanoethylmercapturic acid (CEMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of S-phenyl mercapturic acid (S-PMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.02 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of S-phenyl mercapturic acid (S-PMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.02 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 3-hydroxypropylmercapturic acid (3-HPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 3-hydroxypropylmercapturic acid (3-HPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 2-hydroxypropyl-mercapturic acid (2-HPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 2-hydroxypropyl-mercapturic acid (2-HPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of N-acetyl-S-(2-carbamoylethyl)-l-cysteine (AAMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of N-acetyl-S-(2-carbamoylethyl)-l-cysteine (AAMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-l-cysteine (GAMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-l-cysteine (GAMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 2-hydroxybutenyl-mercapturic acid (2-MHBMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.129 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 2-hydroxybutenyl-mercapturic acid (2-MHBMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.129 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 2-OH-Fluorene (2-OHFLe) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 2-OH-Fluorene (2-OHFLe) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 2-Naphthol amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 2-Naphthol amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 1-OH-Phenanthrene (1-OHPhe) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.005 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 1-OH-Phenanthrene (1-OHPhe) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.005 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 1-hydroxypyrene (1-OHP) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.01 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 1-hydroxypyrene (1-OHP) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.01 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Summary of urine mutagenicity (revertants/24 hours) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Baseline = Day -1. 250 mL urine sample will be concentrated to 1 mL and used for urine mutagenicity testing. The measurement results will be reported as revertants/μL. The urine mutagenicity count in the 24 hour urine will be calculated as: Urine mutagenicity (revertants/24 hour) = Urine mutagenicity (revertants/250 mL) x urine volume/ urine sample volume in mL Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of urine mutagenicity percent change from Baseline (%) by study group and study day is presented. Baseline = Day -1. 250 mL urine sample will be concentrated to 1 mL and used for urine mutagenicity testing. The measurement results will be reported as revertants/μL. The urine mutagenicity count in the 24 hour urine will be calculated as: Urine mutagenicity (revertants/24 hour) = Urine mutagenicity (revertants/250 mL) x urine volume/ urine sample volume in mL % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Summary of whole blood carboxyhemoglobin [COHb] (% saturation) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Baseline = Day -1. The blood sample for COHb was collected approximately 21:30 on Days -1, 5, and 7 after subjects abstained from product use, as appropriate, for at least 15 minutes prior to blood draw for COHb. Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Baseline (Day -1), Day 5 and Day 7 |
| Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of whole blood carboxyhemoglobin (COHb) percent change from Baseline (%) is presented. Subjects with valid sample results are included. Baseline = Day -1. The blood sample for COHb was collected approximately 21:30 on Days -1, 5, and 7 after subjects abstained from product use, as appropriate, for at least 15 minutes prior to blood draw for COHb. % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Day 5 and Day 7 |
| Cigarette Consumption by Study Group and Study Day (mITT Population) | Summary of cigarette consumption, as number of cigarettes smoked per day (CPD), by study group and study day is presented. Baseline = Average of Days -2 and -1. | Day -1 and Day -2 (Baseline), Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 |
| Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Summary of VERVE® Product Used Per Day by Study Group and Study Day is presented. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall). | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 |
| Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Summary of average VERVE® product use duration (minutes) by Study Group and Study Day is presented. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall). | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 |
| Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Summary of total duration (minutes) of VERVE® product per day by Study Group and Study Day. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall). | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 |
| Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | Summary of subject responses to "Use the Product (Cigarette) Again" Bipolar Visual Analogue Scale (VAS) Scores for cigarettes is presented. The Use the Product Again Bipolar VAS is a 100 mm scale ranging from 0 mm ("Definitely Would Not") to 100 mm ("Definitely Would"). The bipolar score is calculated by subtracting 50 from the original VAS score, then categorizing into three categories: -50 to <0, 0, and >0 to 50. Higher scores are associated with greater willingness to use the cigarettes again. Mean and standard deviation of the bipolar VAS score per category is shown. The "Use the Product Again" VAS Score was given to subjects on Day 7 at 21:30 (±30 minutes) during the product use period. The data shown are the means calculated from only those participants with scores in the corresponding category ('-50 to <0', '0' and '>0 to 50'). | Data collected on Day 7 at 21:30 (±30 minutes) during the product use period |
| Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | Summary of subject responses to "Use the Product (VERVE®) Again" Bipolar Visual Analogue Scale (VAS) Scores for the VERVE® test products are presented. The Use the Product Again Bipolar VAS is a 100 mm scale ranging from 0 mm ("Definitely Would Not") to 100 mm ("Definitely Would"). The bipolar score is calculated by subtracting 50 from the original VAS score, then categorizing into three categories: -50 to <0, 0, and >0 to 50. Higher scores are associated with greater willingness to use the VERVE® product again. Mean and standard deviation of the bipolar VAS score per category is shown. The "Use the Product Again" VAS Score was given to subjects on Day 7 at 21:30 (±30 minutes) during the product use period. The data shown are the means calculated from only those participants with scores in the corresponding category ('-50 to <0', '0' and '>0 to 50'). | Data collected on Day 7 at 21:30 (±30 minutes) during the product use period |
| Neptune City |
| New Jersey |
| 07753 |
| United States |
| Enrollment Closed |
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| Failure To Meet Randomization Criteria |
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| Withdrawal by Subject |
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Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days. |
| BG002 | GROUP 2: OTDN Product 1 | Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days. OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs) |
| BG003 | GROUP 3: OTDN Product 2 | Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days. OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews) |
| BG004 | GROUP 4: OTDN Product 1 | Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days. OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs) |
| BG005 | GROUP 5: OTDN Product 2 | Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days. OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews) |
| BG006 | GROUP 6: Tobacco Cessation | Subjects will completely stop all tobacco product usage for 7 days. |
| BG007 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kg |
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| Height | Mean | Standard Deviation | cm |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
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| Highest Grade of School | Count of Participants | Participants |
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| Annual Income | Count of Participants | Participants |
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| Daily Cigarette Use | Data was collected from subject responses at screening reporting the number of cigarettes smoked per day (CPD). | Mean | Standard Deviation | Cigarettes per day |
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| Years Smoked | Data collected from subject tobacco use history. | Mean | Standard Deviation | years |
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| Fagerström Test for Cigarette Dependence | The Fagerström Test assesses an individual's dependence on nicotine. It consists of Yes/No and multiple choice questions where each response is assigned a value from 0 to 1 (for yes/no questions) or 0 to 3 (for multiple choice questions). Values are summed to yield a total score with a minimum score of 0 points and a maximum score of 10 points. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. | Mean | Standard Deviation | points |
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| Cigarette Brand Style History Summary | Data was collected on subjects' own brand of cigarettes. The categories refer to cigarette brand, flavor, style and size, respectively. | Count of Participants | Participants |
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| ID | Title | Description |
|---|
| OG000 | GROUP 1: Continue Smoking | Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days. |
| OG001 | GROUP 2: OTDN Product 1 | Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days. OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs) |
| OG002 | GROUP 3: OTDN Product 2 | Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days. OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews) |
| OG003 | GROUP 4: OTDN Product 1 | Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days. OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs) |
| OG004 | GROUP 5: OTDN Product 2 | Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days. OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews) |
| OG005 | GROUP 6: Tobacco Cessation | Subjects will completely stop all tobacco product usage for 7 days. |
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| Primary | Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Summary of N-nitrosonornicotine (NNN) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.500 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ng/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of N-nitrosonornicotine (NNN) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.500 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Summary of nicotine equivalents amount excreted (mg/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) for each metabolite were set to one-half of the LLOQ for the calculation of nicotine equivalents. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Nicotine equivalents (mg/g creatinine) = nicotine equivalents (μg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | mg/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of nicotine equivalents amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) for each metabolite were set to one-half of the LLOQ for the calculation of nicotine equivalents. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Nicotine equivalents (mg/g creatinine) = nicotine equivalents (μg/mL) x 100 / creatinine (mg/dL) % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 2-aminonaphthalene (2-AN) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.7 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ng/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 2-aminonaphthalene (2-AN) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.7 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 4-aminobiphenyl (4-ABP) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.5 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ng/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 4-aminobiphenyl (4-ABP) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.5 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 2-hydroxyethyl mercapturic acid (HEMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.2 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ug/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 2-hydroxyethyl mercapturic acid (HEMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.2 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 2-cyanoethylmercapturic acid (CEMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ug/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 2-cyanoethylmercapturic acid (CEMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of S-phenyl mercapturic acid (S-PMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.02 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ug/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of S-phenyl mercapturic acid (S-PMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.02 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ug/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 3-hydroxypropylmercapturic acid (3-HPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ug/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 3-hydroxypropylmercapturic acid (3-HPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 2-hydroxypropyl-mercapturic acid (2-HPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ug/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 2-hydroxypropyl-mercapturic acid (2-HPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of N-acetyl-S-(2-carbamoylethyl)-l-cysteine (AAMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ug/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of N-acetyl-S-(2-carbamoylethyl)-l-cysteine (AAMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-l-cysteine (GAMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ug/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-l-cysteine (GAMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 2-hydroxybutenyl-mercapturic acid (2-MHBMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.129 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ug/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 2-hydroxybutenyl-mercapturic acid (2-MHBMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.129 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 2-OH-Fluorene (2-OHFLe) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ug/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 2-OH-Fluorene (2-OHFLe) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 2-Naphthol amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ug/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 2-Naphthol amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 1-OH-Phenanthrene (1-OHPhe) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.005 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ug/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 1-OH-Phenanthrene (1-OHPhe) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.005 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Summary of 1-hydroxypyrene (1-OHP) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.01 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | ug/24 hour | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of 1-hydroxypyrene (1-OHP) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.01 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Summary of urine mutagenicity (revertants/24 hours) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Baseline = Day -1. 250 mL urine sample will be concentrated to 1 mL and used for urine mutagenicity testing. The measurement results will be reported as revertants/μL. The urine mutagenicity count in the 24 hour urine will be calculated as: Urine mutagenicity (revertants/24 hour) = Urine mutagenicity (revertants/250 mL) x urine volume/ urine sample volume in mL Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | revertants/24 hours | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of urine mutagenicity percent change from Baseline (%) by study group and study day is presented. Baseline = Day -1. 250 mL urine sample will be concentrated to 1 mL and used for urine mutagenicity testing. The measurement results will be reported as revertants/μL. The urine mutagenicity count in the 24 hour urine will be calculated as: Urine mutagenicity (revertants/24 hour) = Urine mutagenicity (revertants/250 mL) x urine volume/ urine sample volume in mL % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Summary of whole blood carboxyhemoglobin [COHb] (% saturation) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Baseline = Day -1. The blood sample for COHb was collected approximately 21:30 on Days -1, 5, and 7 after subjects abstained from product use, as appropriate, for at least 15 minutes prior to blood draw for COHb. Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | % Saturation | Baseline (Day -1), Day 5 and Day 7 |
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| Secondary | Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Summary of whole blood carboxyhemoglobin (COHb) percent change from Baseline (%) is presented. Subjects with valid sample results are included. Baseline = Day -1. The blood sample for COHb was collected approximately 21:30 on Days -1, 5, and 7 after subjects abstained from product use, as appropriate, for at least 15 minutes prior to blood draw for COHb. % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | percentage of change | Day 5 and Day 7 |
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| Secondary | Cigarette Consumption by Study Group and Study Day (mITT Population) | Summary of cigarette consumption, as number of cigarettes smoked per day (CPD), by study group and study day is presented. Baseline = Average of Days -2 and -1. | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure. Subjects in Groups 4, 5, and 6 were instructed to refrain from smoking cigarettes after Day -1 in compliance with the product use group assignment. No CPD data was collected for these groups on Days 1 through 7 and the Number of Participants Analyzed is reported as '0' in the data table. | Posted | Mean | Standard Deviation | cigarettes per day | Day -1 and Day -2 (Baseline), Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 |
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| Secondary | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Summary of VERVE® Product Used Per Day by Study Group and Study Day is presented. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall). | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | products per day | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 |
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| Secondary | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Summary of average VERVE® product use duration (minutes) by Study Group and Study Day is presented. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall). | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | minutes | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 |
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| Secondary | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Summary of total duration (minutes) of VERVE® product per day by Study Group and Study Day. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall). | Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure | Posted | Mean | Standard Deviation | minutes | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 |
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| Secondary | Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | Summary of subject responses to "Use the Product (Cigarette) Again" Bipolar Visual Analogue Scale (VAS) Scores for cigarettes is presented. The Use the Product Again Bipolar VAS is a 100 mm scale ranging from 0 mm ("Definitely Would Not") to 100 mm ("Definitely Would"). The bipolar score is calculated by subtracting 50 from the original VAS score, then categorizing into three categories: -50 to <0, 0, and >0 to 50. Higher scores are associated with greater willingness to use the cigarettes again. Mean and standard deviation of the bipolar VAS score per category is shown. The "Use the Product Again" VAS Score was given to subjects on Day 7 at 21:30 (±30 minutes) during the product use period. The data shown are the means calculated from only those participants with scores in the corresponding category ('-50 to <0', '0' and '>0 to 50'). | The mITT population consisted of all randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure. Only subjects who were smoked their own cigarette brand were asked to complete the "Use Product (Cigarette) Again" VAS score. | Posted | Mean | Standard Deviation | units on a scale | Data collected on Day 7 at 21:30 (±30 minutes) during the product use period |
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| Secondary | Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | Summary of subject responses to "Use the Product (VERVE®) Again" Bipolar Visual Analogue Scale (VAS) Scores for the VERVE® test products are presented. The Use the Product Again Bipolar VAS is a 100 mm scale ranging from 0 mm ("Definitely Would Not") to 100 mm ("Definitely Would"). The bipolar score is calculated by subtracting 50 from the original VAS score, then categorizing into three categories: -50 to <0, 0, and >0 to 50. Higher scores are associated with greater willingness to use the VERVE® product again. Mean and standard deviation of the bipolar VAS score per category is shown. The "Use the Product Again" VAS Score was given to subjects on Day 7 at 21:30 (±30 minutes) during the product use period. The data shown are the means calculated from only those participants with scores in the corresponding category ('-50 to <0', '0' and '>0 to 50'). | The mITT population consisted of all randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure. Only subjects who used the VERVE® product were asked to complete the "Use Product (VERVE®) Again" VAS score. | Posted | Mean | Standard Deviation | units on a scale | Data collected on Day 7 at 21:30 (±30 minutes) during the product use period |
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| 0 |
| 18 |
| 0 |
| 18 |
| 66 |
| 231 |
| EG001 | GROUP 1: Continue Smoking | Subjects will be asked to continue smoking their OB cigarettes ad libitum for 7 days. | 0 | 40 | 0 | 40 | 6 | 40 |
| EG002 | GROUP 2: OTDN Product 1 | Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days. OTDN product 1: Oral tobacco-derived nicotine product | 0 | 42 | 0 | 42 | 12 | 42 |
| EG003 | GROUP 3: OTDN Product 2 | Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days. OTDN product 2: Oral tobacco-derived nicotine product | 0 | 41 | 0 | 41 | 14 | 41 |
| EG004 | GROUP 4: OTDN Product 1 | Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days. OTDN product 1: Oral tobacco-derived nicotine product | 0 | 30 | 0 | 30 | 14 | 30 |
| EG005 | GROUP 5: OTDN Product 2 | Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days. OTDN product 2: Oral tobacco-derived nicotine product | 0 | 30 | 0 | 30 | 14 | 30 |
| EG006 | GROUP 6: Tobacco Cessation | Subjects will completely stop all tobacco product usage for 7 days. Tobacco Cessation: Tobacco Cessation | 0 | 30 | 0 | 30 | 0 | 30 |
| Eye irritation | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Gingival pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Salivary gland enlargement | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Drug withdrawal syndrome | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pyuria | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Sputum abnormal | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Subcutaneous abscess | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
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Not provided
Not provided
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| Day 7 |
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| Day 5 |
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| Day 7 |
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| Change from Baseline (Day 5) |
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| Change from Baseline (Day 7) |
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Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.
Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.632 | 2-Sided | 95 | 2.321 | 2.943 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.006 | 2-Sided | 95 | 1.714 | 2.298 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.143 | 2-Sided | 95 | 1.847 | 2.440 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.987 | 2-Sided | 95 | 1.690 | 2.284 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.261 | 2-Sided | 95 | 1.964 | 2.559 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | 0.1658 | Mean Difference (Net) | -0.263 | 2-Sided | 95 | -0.635 | 0.109 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | 0.0007 | Mean Difference (Net) | -0.659 | 2-Sided | 95 | -1.036 | -0.282 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | 0.1055 | Mean Difference (Net) | -0.302 | 2-Sided | 95 | -0.667 | 0.064 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Non-Inferiority | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | 0.2040 | Mean Difference (Net) | -0.243 | 2-Sided | 95 | -0.617 | 0.132 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | 0.1829 | Mean Difference (Net) | -0.244 | 2-Sided | 95 | -0.603 | 0.116 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | 0.1801 | Mean Difference (Net) | -0.248 | 2-Sided | 95 | -0.612 | 0.115 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0391 | Mean Difference (Net) | -0.622 | 2-Sided | 95 | -1.225 | -0.019 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.1864 | Mean Difference (Net) | -0.489 | 2-Sided | 95 | -1.096 | 0.119 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0310 | Mean Difference (Net) | -0.642 | 2-Sided | 95 | -1.246 | -0.037 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0310 | Mean Difference (Net) | -0.642 | 2-Sided | 95 | -1.246 | -0.037 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.891 | 2-Sided | 95 | -3.580 | -2.202 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -3.291 | 2-Sided | 95 | -3.985 | -2.597 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.930 | 2-Sided | 95 | -3.605 | -2.255 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.875 | 2-Sided | 95 | -3.559 | -2.190 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.250 | 2-Sided | 95 | 1.604 | 2.896 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.391 | 2-Sided | 95 | 1.737 | 3.046 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.231 | 2-Sided | 95 | 1.582 | 2.879 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.509 | 2-Sided | 95 | 1.857 | 3.162 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | -0.019 | 2-Sided | 95 | -0.743 | 0.705 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.5639 | Mean Difference (Net) | -0.411 | 2-Sided | 95 | -1.142 | 0.320 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | -0.058 | 2-Sided | 95 | -0.771 | 0.656 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.006 | 2-Sided | 95 | -0.721 | 0.732 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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| Day 7 |
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| Day 5 |
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| Day 7 |
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| Change from Baseline (Day 5) |
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| Change from Baseline (Day 7) |
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Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.718 | 2-Sided | 95 | 2.546 | 2.890 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.415 | 2-Sided | 95 | 2.252 | 2.577 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.440 | 2-Sided | 95 | 2.276 | 2.603 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.583 | 2-Sided | 95 | 2.417 | 2.748 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.591 | 2-Sided | 95 | 2.426 | 2.757 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.107 | 2-Sided | 95 | 0.901 | 1.314 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.017 | 2-Sided | 95 | 0.810 | 1.225 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.828 | 2-Sided | 95 | 1.624 | 2.031 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.782 | 2-Sided | 95 | 1.577 | 1.988 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.550 | 2-Sided | 95 | -0.750 | -0.350 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.850 | 2-Sided | 95 | -1.051 | -0.650 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.1608 | Mean Difference (Net) | -0.276 | 2-Sided | 95 | -0.609 | 0.057 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.1575 | Mean Difference (Net) | -0.278 | 2-Sided | 95 | -0.613 | 0.056 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.9728 | Mean Difference (Net) | -0.108 | 2-Sided | 95 | -0.442 | 0.226 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.9262 | Mean Difference (Net) | -0.127 | 2-Sided | 95 | -0.461 | 0.208 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.584 | 2-Sided | 95 | -1.963 | -1.204 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.701 | 2-Sided | 95 | -2.081 | -1.320 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.863 | 2-Sided | 95 | -1.237 | -0.489 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.936 | 2-Sided | 95 | -1.312 | -0.560 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
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Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.508 | 2-Sided | 95 | 3.348 | 3.668 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.891 | 2-Sided | 95 | 2.741 | 3.042 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.873 | 2-Sided | 95 | 2.719 | 3.027 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.928 | 2-Sided | 95 | 2.775 | 3.082 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.896 | 2-Sided | 95 | 2.742 | 3.049 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.864 | 2-Sided | 95 | 0.672 | 1.055 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.786 | 2-Sided | 95 | 0.592 | 0.981 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.641 | 2-Sided | 95 | 0.452 | 0.829 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.485 | 2-Sided | 95 | 0.290 | 0.680 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.747 | 2-Sided | 95 | 0.562 | 0.932 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.833 | 2-Sided | 95 | 0.645 | 1.021 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.579 | 2-Sided | 95 | -0.889 | -0.268 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.635 | 2-Sided | 95 | -0.949 | -0.321 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.542 | 2-Sided | 95 | -0.853 | -0.231 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.613 | 2-Sided | 95 | -0.924 | -0.301 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.606 | 2-Sided | 95 | -2.959 | -2.253 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.722 | 2-Sided | 95 | -3.078 | -2.366 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.829 | 2-Sided | 95 | -3.177 | -2.481 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -3.024 | 2-Sided | 95 | -3.378 | -2.669 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.144 | 2-Sided | 95 | 1.811 | 2.478 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.040 | 2-Sided | 95 | 1.701 | 2.379 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.181 | 2-Sided | 95 | 1.846 | 2.516 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.063 | 2-Sided | 95 | 1.725 | 2.400 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.9705 | Mean Difference (Net) | 0.117 | 2-Sided | 95 | -0.256 | 0.490 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | -0.047 | 2-Sided | 95 | -0.425 | 0.332 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.9835 | Mean Difference (Net) | -0.106 | 2-Sided | 95 | -0.475 | 0.263 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0854 | Mean Difference (Net) | -0.348 | 2-Sided | 95 | -0.725 | 0.029 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.034 | 2-Sided | 95 | 2.927 | 3.141 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.603 | 2-Sided | 95 | 2.483 | 2.722 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.567 | 2-Sided | 95 | 2.465 | 2.670 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.716 | 2-Sided | 95 | 2.595 | 2.838 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.643 | 2-Sided | 95 | 2.541 | 2.746 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.235 | 2-Sided | 95 | 1.083 | 1.386 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.174 | 2-Sided | 95 | 1.045 | 1.304 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.219 | 2-Sided | 95 | 1.070 | 1.368 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.176 | 2-Sided | 95 | 1.046 | 1.306 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.176 | 2-Sided | 95 | 1.029 | 1.322 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.174 | 2-Sided | 95 | 1.049 | 1.300 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.425 | 2-Sided | 95 | -0.669 | -0.181 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.467 | 2-Sided | 95 | -0.677 | -0.256 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0052 | Mean Difference (Net) | -0.311 | 2-Sided | 95 | -0.556 | -0.066 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.391 | 2-Sided | 95 | -0.600 | -0.182 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.793 | 2-Sided | 95 | -2.070 | -1.516 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.859 | 2-Sided | 95 | -2.098 | -1.621 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.809 | 2-Sided | 95 | -2.082 | -1.535 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.858 | 2-Sided | 95 | -2.096 | -1.621 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.427 | 2-Sided | 95 | 1.166 | 1.688 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.393 | 2-Sided | 95 | 1.166 | 1.620 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.541 | 2-Sided | 95 | 1.278 | 1.803 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.469 | 2-Sided | 95 | 1.243 | 1.695 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.9987 | Mean Difference (Net) | 0.059 | 2-Sided | 95 | -0.233 | 0.351 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.000 | 2-Sided | 95 | -0.253 | 0.254 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.9999 | Mean Difference (Net) | 0.043 | 2-Sided | 95 | -0.246 | 0.332 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.002 | 2-Sided | 95 | -0.251 | 0.254 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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| Day 7 |
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| Day 7 |
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| Change from Baseline (Day 5) |
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Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.398 | 2-Sided | 95 | 2.253 | 2.543 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.303 | 2-Sided | 95 | 2.187 | 2.420 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.250 | 2-Sided | 95 | 2.112 | 2.389 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.285 | 2-Sided | 95 | 2.166 | 2.404 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.272 | 2-Sided | 95 | 2.133 | 2.412 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.992 | 2-Sided | 95 | 1.844 | 2.140 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.894 | 2-Sided | 95 | 1.719 | 2.069 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.102 | 2-Sided | 95 | 1.955 | 2.248 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.075 | 2-Sided | 95 | 1.900 | 2.250 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.890 | 2-Sided | 95 | 1.746 | 2.033 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.944 | 2-Sided | 95 | 1.775 | 2.114 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.8674 | Mean Difference (Net) | -0.104 | 2-Sided | 95 | -0.345 | 0.137 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.6519 | Mean Difference (Net) | -0.148 | 2-Sided | 95 | -0.429 | 0.133 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.7301 | Mean Difference (Net) | -0.122 | 2-Sided | 95 | -0.363 | 0.119 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.8076 | Mean Difference (Net) | -0.126 | 2-Sided | 95 | -0.405 | 0.154 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0004 | Mean Difference (Net) | -0.415 | 2-Sided | 95 | -0.689 | -0.142 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0002 | Mean Difference (Net) | -0.504 | 2-Sided | 95 | -0.822 | -0.185 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0183 | Mean Difference (Net) | -0.306 | 2-Sided | 95 | -0.578 | -0.034 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0443 | Mean Difference (Net) | -0.323 | 2-Sided | 95 | -0.641 | -0.005 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0002 | Mean Difference (Net) | 0.414 | 2-Sided | 95 | 0.155 | 0.672 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0454 | Mean Difference (Net) | 0.306 | 2-Sided | 95 | 0.004 | 0.608 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0004 | Mean Difference (Net) | 0.396 | 2-Sided | 95 | 0.136 | 0.655 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0261 | Mean Difference (Net) | 0.328 | 2-Sided | 95 | 0.026 | 0.630 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.9455 | Mean Difference (Net) | 0.102 | 2-Sided | 95 | -0.187 | 0.392 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.9999 | Mean Difference (Net) | -0.050 | 2-Sided | 95 | -0.387 | 0.287 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.2633 | Mean Difference (Net) | 0.212 | 2-Sided | 95 | -0.074 | 0.498 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.8769 | Mean Difference (Net) | 0.130 | 2-Sided | 95 | -0.205 | 0.465 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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| Day 5 |
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| Day 7 |
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| Change from Baseline (Day 5) |
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Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (PP Population)
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 5.436 | 2-Sided | 95 | 5.324 | 5.548 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.957 | 2-Sided | 95 | 4.860 | 5.053 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.974 | 2-Sided | 95 | 4.867 | 5.081 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.984 | 2-Sided | 95 | 4.886 | 5.082 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.975 | 2-Sided | 95 | 4.868 | 5.082 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.490 | 2-Sided | 95 | 3.367 | 3.612 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.347 | 2-Sided | 95 | 3.212 | 3.483 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.539 | 2-Sided | 95 | 3.418 | 3.660 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.419 | 2-Sided | 95 | 3.284 | 3.554 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.492 | 2-Sided | 95 | 3.373 | 3.611 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.437 | 2-Sided | 95 | 3.306 | 3.568 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.461 | 2-Sided | 95 | -0.660 | -0.262 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.462 | 2-Sided | 95 | -0.679 | -0.244 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.433 | 2-Sided | 95 | -0.633 | -0.233 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.461 | 2-Sided | 95 | -0.678 | -0.244 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.928 | 2-Sided | 95 | -2.154 | -1.701 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.089 | 2-Sided | 95 | -2.336 | -1.842 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.879 | 2-Sided | 95 | -2.102 | -1.656 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.017 | 2-Sided | 95 | -2.262 | -1.772 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.465 | 2-Sided | 95 | 1.250 | 1.679 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.537 | 2-Sided | 95 | 1.303 | 1.772 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.492 | 2-Sided | 95 | 1.277 | 1.707 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (PP Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.538 | 2-Sided | 95 | 1.304 | 1.772 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (PP Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | -0.003 | 2-Sided | 95 | -0.242 | 0.237 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (PP Population) | Mixed Models Analysis | 0.9399 | Mean Difference (Net) | -0.090 | 2-Sided | 95 | -0.351 | 0.172 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (PP Population) | Mixed Models Analysis | 0.9993 | Mean Difference (Net) | 0.047 | 2-Sided | 95 | -0.190 | 0.283 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (PP Population) |
| Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (PP Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | -0.018 | 2-Sided | 95 | -0.278 | 0.242 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (PP Population) |
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Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.788 | 2-Sided | 95 | 1.622 | 1.954 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.290 | 2-Sided | 95 | 1.145 | 1.462 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.304 | 2-Sided | 95 | 1.134 | 1.447 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.353 | 2-Sided | 95 | 1.194 | 1.513 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.313 | 2-Sided | 95 | 1.153 | 1.472 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.956 | 2-Sided | 95 | -1.155 | -0.756 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.114 | 2-Sided | 95 | -1.315 | -0.913 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.999 | 2-Sided | 95 | -1.195 | -0.803 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.164 | 2-Sided | 95 | -1.364 | -0.964 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.775 | 2-Sided | 95 | -0.969 | -0.582 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.795 | 2-Sided | 95 | -0.990 | -0.600 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0002 | Mean Difference (Net) | -0.514 | 2-Sided | 95 | -0.836 | -0.193 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0005 | Mean Difference (Net) | -0.484 | 2-Sided | 95 | -0.808 | -0.160 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0014 | Mean Difference (Net) | -0.452 | 2-Sided | 95 | -0.775 | -0.128 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0007 | Mean Difference (Net) | -0.475 | 2-Sided | 95 | -0.799 | -0.152 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.760 | 2-Sided | 95 | -3.127 | -2.394 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.902 | 2-Sided | 95 | -3.271 | -2.533 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.804 | 2-Sided | 95 | -3.165 | -2.443 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.952 | 2-Sided | 95 | -3.317 | -2.587 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.066 | 2-Sided | 95 | 1.719 | 2.413 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.099 | 2-Sided | 95 | 1.748 | 2.449 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.129 | 2-Sided | 95 | 1.779 | 2.478 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.107 | 2-Sided | 95 | 1.756 | 2.459 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.7678 | Mean Difference (Net) | -0.180 | 2-Sided | 95 | -0.569 | 0.209 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.1691 | Mean Difference (Net) | -0.319 | 2-Sided | 95 | -0.711 | 0.073 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.5178 | Mean Difference (Net) | -0.224 | 2-Sided | 95 | -0.606 | 0.158 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0699 | Mean Difference (Net) | -0.369 | 2-Sided | 95 | -0.757 | 0.018 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 6.197 | 2-Sided | 95 | 6.082 | 6.312 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 5.798 | 2-Sided | 95 | 5.690 | 5.906 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 5.820 | 2-Sided | 95 | 5.710 | 5.930 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 5.863 | 2-Sided | 95 | 5.753 | 5.974 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 5.816 | 2-Sided | 95 | 5.706 | 5.927 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.947 | 2-Sided | 95 | 4.809 | 5.084 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.913 | 2-Sided | 95 | 4.774 | 5.052 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.862 | 2-Sided | 95 | 4.727 | 4.998 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.938 | 2-Sided | 95 | 4.799 | 5.076 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.826 | 2-Sided | 95 | 4.693 | 4.959 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.902 | 2-Sided | 95 | 4.767 | 5.037 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.379 | 2-Sided | 95 | -0.602 | -0.156 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.376 | 2-Sided | 95 | -0.601 | -0.152 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0014 | Mean Difference (Net) | -0.314 | 2-Sided | 95 | -0.537 | -0.090 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.381 | 2-Sided | 95 | -0.604 | -0.157 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.230 | 2-Sided | 95 | -1.484 | -0.977 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.284 | 2-Sided | 95 | -1.539 | -1.029 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.315 | 2-Sided | 95 | -1.564 | -1.065 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.259 | 2-Sided | 95 | -1.512 | -1.006 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.972 | 2-Sided | 95 | 0.732 | 1.211 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.918 | 2-Sided | 95 | 0.676 | 1.161 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.037 | 2-Sided | 95 | 0.797 | 1.278 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.914 | 2-Sided | 95 | 0.672 | 1.156 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.7939 | Mean Difference (Net) | 0.121 | 2-Sided | 95 | -0.147 | 0.388 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.011 | 2-Sided | 95 | -0.260 | 0.281 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.036 | 2-Sided | 95 | -0.228 | 0.301 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.036 | 2-Sided | 95 | -0.233 | 0.305 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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| Day 7 |
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| Day 5 |
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| Day 7 |
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| Change from Baseline (Day 5) |
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| Change from Baseline (Day 7) |
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Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 7.368 | 2-Sided | 95 | 7.251 | 7.485 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 6.883 | 2-Sided | 95 | 6.773 | 6.994 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 6.892 | 2-Sided | 95 | 6.780 | 7.004 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 6.942 | 2-Sided | 95 | 6.829 | 7.054 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 6.896 | 2-Sided | 95 | 6.784 | 7.008 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 5.879 | 2-Sided | 95 | 5.739 | 6.019 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 5.804 | 2-Sided | 95 | 5.662 | 5.946 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 5.916 | 2-Sided | 95 | 5.778 | 6.054 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 5.917 | 2-Sided | 95 | 5.775 | 6.058 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 6.017 | 2-Sided | 95 | 5.881 | 6.153 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 6.012 | 2-Sided | 95 | 5.874 | 6.149 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.484 | 2-Sided | 95 | -0.711 | -0.257 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.476 | 2-Sided | 95 | -0.705 | -0.248 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.426 | 2-Sided | 95 | -0.654 | -0.198 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.472 | 2-Sided | 95 | -0.701 | -0.244 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.489 | 2-Sided | 95 | -1.747 | -1.230 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Final Values) | -1.564 | 2-Sided | 95 | -1.825 | -1.304 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.451 | 2-Sided | 95 | -1.706 | -1.197 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.452 | 2-Sided | 95 | -1.710 | -1.193 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.866 | 2-Sided | 95 | 0.622 | 1.110 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.880 | 2-Sided | 95 | 0.633 | 1.128 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.924 | 2-Sided | 95 | 0.680 | 1.169 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.884 | 2-Sided | 95 | 0.638 | 1.131 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.6800 | Mean Difference (Net) | -0.138 | 2-Sided | 95 | -0.411 | 0.134 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.2371 | Mean Difference (Net) | -0.208 | 2-Sided | 95 | -0.483 | 0.068 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.9133 | Mean Difference (Net) | -0.101 | 2-Sided | 95 | -0.371 | 0.169 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.9432 | Mean Difference (Net) | -0.095 | 2-Sided | 95 | -0.370 | 0.180 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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| Day 7 |
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| Day 5 |
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| Day 7 |
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| Change from Baseline (Day 5) |
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| Change from Baseline (Day 7) |
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Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.491 | 2-Sided | 95 | 4.371 | 4.610 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.150 | 2-Sided | 95 | 4.027 | 4.272 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.128 | 2-Sided | 95 | 4.014 | 4.242 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.176 | 2-Sided | 95 | 4.051 | 4.301 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.139 | 2-Sided | 95 | 4.024 | 4.254 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.997 | 2-Sided | 95 | 2.842 | 3.153 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.994 | 2-Sided | 95 | 2.849 | 3.138 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.317 | 2-Sided | 95 | 3.164 | 3.470 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.342 | 2-Sided | 95 | 3.199 | 3.486 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.036 | 2-Sided | 95 | 2.886 | 3.187 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.159 | 2-Sided | 95 | 3.019 | 3.299 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0008 | Mean Difference (Net) | -0.363 | 2-Sided | 95 | -0.613 | -0.113 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0003 | Mean Difference (Net) | -0.362 | 2-Sided | 95 | -0.595 | -0.129 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0026 | Mean Difference (Net) | -0.337 | 2-Sided | 95 | -0.588 | -0.085 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0004 | Mean Difference (Net) | -0.351 | 2-Sided | 95 | -0.584 | -0.118 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.515 | 2-Sided | 95 | -1.800 | -1.230 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.497 | 2-Sided | 95 | -1.762 | -1.231 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.196 | 2-Sided | 95 | -1.477 | -0.915 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.148 | 2-Sided | 95 | -1.410 | -0.886 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.113 | 2-Sided | 95 | 0.844 | 1.382 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.969 | 2-Sided | 95 | 0.717 | 1.221 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.139 | 2-Sided | 95 | 0.869 | 1.410 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.980 | 2-Sided | 95 | 0.728 | 1.231 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | -0.039 | 2-Sided | 95 | -0.340 | 0.262 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.5184 | Mean Difference (Net) | -0.166 | 2-Sided | 95 | -0.447 | 0.115 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0743 | Mean Difference (Net) | 0.280 | 2-Sided | 95 | -0.017 | 0.578 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.3889 | Mean Difference (Net) | 0.183 | 2-Sided | 95 | -0.095 | 0.462 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 5.204 | 2-Sided | 95 | 5.106 | 5.302 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 5.005 | 2-Sided | 95 | 4.902 | 5.108 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.958 | 2-Sided | 95 | 4.864 | 5.051 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 5.114 | 2-Sided | 95 | 5.009 | 5.219 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 5.052 | 2-Sided | 95 | 4.958 | 5.146 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.539 | 2-Sided | 95 | 4.407 | 4.671 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.415 | 2-Sided | 95 | 4.295 | 4.534 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.431 | 2-Sided | 95 | 4.302 | 4.560 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.361 | 2-Sided | 95 | 4.243 | 4.480 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.486 | 2-Sided | 95 | 4.359 | 4.612 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 4.588 | 2-Sided | 95 | 4.473 | 4.703 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0073 | Mean Difference (Net) | -0.259 | 2-Sided | 95 | -0.469 | -0.049 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0041 | Mean Difference (Net) | -0.246 | 2-Sided | 95 | -0.438 | -0.055 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.3080 | Mean Difference (Net) | -0.150 | 2-Sided | 95 | -0.361 | 0.061 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.1982 | Mean Difference (Net) | -0.152 | 2-Sided | 95 | -0.343 | 0.039 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.725 | 2-Sided | 95 | -0.965 | -0.486 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.790 | 2-Sided | 95 | -1.008 | -0.571 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.833 | 2-Sided | 95 | -1.069 | -0.597 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.843 | 2-Sided | 95 | -1.059 | -0.627 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.520 | 2-Sided | 95 | 0.294 | 0.745 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.370 | 2-Sided | 95 | 0.163 | 0.577 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.628 | 2-Sided | 95 | 0.402 | 0.855 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.464 | 2-Sided | 95 | 0.257 | 0.670 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.9984 | Mean Difference (Net) | 0.053 | 2-Sided | 95 | -0.200 | 0.306 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.2491 | Mean Difference (Net) | -0.173 | 2-Sided | 95 | -0.405 | 0.058 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.9977 | Mean Difference (Net) | -0.054 | 2-Sided | 95 | -0.304 | 0.195 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0554 | Mean Difference (Net) | -0.227 | 2-Sided | 95 | -0.456 | 0.003 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.262 | 2-Sided | 95 | 3.176 | 3.348 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.120 | 2-Sided | 95 | 3.039 | 3.202 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.099 | 2-Sided | 95 | 3.017 | 3.181 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.182 | 2-Sided | 95 | 3.100 | 3.264 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.149 | 2-Sided | 95 | 3.066 | 3.231 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.777 | 2-Sided | 95 | 2.673 | 2.881 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.651 | 2-Sided | 95 | 2.546 | 2.756 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.720 | 2-Sided | 95 | 2.618 | 2.823 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.649 | 2-Sided | 95 | 2.544 | 2.753 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.751 | 2-Sided | 95 | 2.651 | 2.851 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.819 | 2-Sided | 95 | 2.718 | 2.919 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0377 | Mean Difference (Net) | -0.173 | 2-Sided | 95 | -0.340 | -0.006 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0643 | Mean Difference (Net) | -0.163 | 2-Sided | 95 | -0.331 | 0.006 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.3875 | Mean Difference (Net) | -0.112 | 2-Sided | 95 | -0.279 | 0.056 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.3725 | Mean Difference (Net) | -0.113 | 2-Sided | 95 | -0.280 | 0.054 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.516 | 2-Sided | 95 | -0.706 | -0.327 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.611 | 2-Sided | 95 | -0.802 | -0.420 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.573 | 2-Sided | 95 | -0.760 | -0.386 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.613 | 2-Sided | 95 | -0.803 | -0.423 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.369 | 2-Sided | 95 | 0.190 | 0.548 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0003 | Mean Difference (Net) | 0.280 | 2-Sided | 95 | 0.099 | 0.462 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.431 | 2-Sided | 95 | 0.251 | 0.611 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.330 | 2-Sided | 95 | 0.149 | 0.511 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.026 | 2-Sided | 95 | -0.176 | 0.228 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.1589 | Mean Difference (Net) | -0.168 | 2-Sided | 95 | -0.371 | 0.036 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.9999 | Mean Difference (Net) | -0.031 | 2-Sided | 95 | -0.230 | 0.168 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.1453 | Mean Difference (Net) | -0.170 | 2-Sided | 95 | -0.372 | 0.032 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.104 | 2-Sided | 95 | 0.807 | 1.400 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.606 | 2-Sided | 95 | 0.326 | 0.886 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | 0.0011 | Mean Difference (Net) | 0.476 | 2-Sided | 95 | 0.192 | 0.760 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | 0.0006 | Mean Difference (Net) | 0.505 | 2-Sided | 95 | 0.219 | 0.790 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.775 | 2-Sided | 95 | 0.490 | 1.060 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.116 | 2-Sided | 95 | -2.472 | -1.761 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.016 | 2-Sided | 95 | -2.376 | -1.656 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.605 | 2-Sided | 95 | -1.958 | -1.253 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.642 | 2-Sided | 95 | -2.003 | -1.282 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.578 | 2-Sided | 95 | -1.922 | -1.234 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.726 | 2-Sided | 95 | -2.074 | -1.378 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.1579 | Mean Difference (Net) | -0.479 | 2-Sided | 95 | -1.054 | 0.097 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0260 | Mean Difference (Net) | -0.628 | 2-Sided | 95 | -1.207 | -0.048 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0483 | Mean Difference (Net) | -0.580 | 2-Sided | 95 | -1.158 | -0.003 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.5842 | Mean Difference (Net) | -0.329 | 2-Sided | 95 | -0.906 | 0.249 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -3.201 | 2-Sided | 95 | -3.856 | -2.546 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -3.119 | 2-Sided | 95 | -3.779 | -2.460 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.690 | 2-Sided | 95 | -3.338 | -2.043 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.746 | 2-Sided | 95 | -3.402 | -2.090 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.184 | 2-Sided | 95 | 1.565 | 2.803 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.202 | 2-Sided | 95 | 1.576 | 2.828 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.083 | 2-Sided | 95 | 1.461 | 2.704 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.501 | 2-Sided | 95 | 1.876 | 3.126 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.2085 | Mean Difference (Net) | -0.538 | 2-Sided | 95 | -1.231 | 0.154 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.8557 | Mean Difference (Net) | -0.289 | 2-Sided | 95 | -0.988 | 0.410 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | -0.027 | 2-Sided | 95 | -0.713 | 0.658 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.084 | 2-Sided | 95 | -0.612 | 0.780 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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| Day 7 |
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| Day 5 |
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| Day 7 |
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| Change from Baseline (Day 5) |
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| Change from Baseline (Day 7) |
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Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.309 | 2-Sided | 95 | 0.902 | 1.716 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.996 | 2-Sided | 95 | 0.615 | 1.377 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | 0.0003 | Mean Difference (Net) | 0.728 | 2-Sided | 95 | 0.339 | 1.116 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.987 | 2-Sided | 95 | 0.593 | 1.381 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.865 | 2-Sided | 95 | 0.475 | 1.254 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | 0.0768 | Mean Difference (Net) | 0.436 | 2-Sided | 95 | -0.047 | 0.920 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | 0.7155 | Mean Difference (Net) | 0.091 | 2-Sided | 95 | -0.400 | 0.583 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | 0.3282 | Mean Difference (Net) | 0.237 | 2-Sided | 95 | -0.239 | 0.713 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | 0.3578 | Mean Difference (Net) | -0.230 | 2-Sided | 95 | -0.722 | 0.262 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | 0.1638 | Mean Difference (Net) | 0.338 | 2-Sided | 95 | -0.138 | 0.814 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | 0.8384 | Mean Difference (Net) | -0.050 | 2-Sided | 95 | -0.533 | 0.433 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | -0.086 | 2-Sided | 95 | -0.869 | 0.698 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.2808 | Mean Difference (Net) | -0.581 | 2-Sided | 95 | -1.377 | 0.214 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | -0.095 | 2-Sided | 95 | -0.887 | 0.698 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.6018 | Mean Difference (Net) | -0.444 | 2-Sided | 95 | -1.237 | 0.349 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.2935 | Mean Difference (Net) | -0.645 | 2-Sided | 95 | -1.536 | 0.246 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0023 | Mean Difference (Net) | -1.218 | 2-Sided | 95 | -2.120 | -0.315 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0669 | Mean Difference (Net) | -0.844 | 2-Sided | 95 | -1.723 | 0.035 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.539 | 2-Sided | 95 | -2.438 | -0.640 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.2120 | Mean Difference (Net) | 0.658 | 2-Sided | 95 | -0.192 | 1.509 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0993 | Mean Difference (Net) | 0.778 | 2-Sided | 95 | -0.087 | 1.642 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.2347 | Mean Difference (Net) | 0.649 | 2-Sided | 95 | -0.211 | 1.509 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0320 | Mean Difference (Net) | 0.915 | 2-Sided | 95 | 0.052 | 1.778 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.099 | 2-Sided | 95 | -0.849 | 1.047 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.9999 | Mean Difference (Net) | 0.141 | 2-Sided | 95 | -0.820 | 1.103 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | -0.101 | 2-Sided | 95 | -1.038 | 0.837 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.9995 | Mean Difference (Net) | -0.180 | 2-Sided | 95 | -1.139 | 0.779 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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| Day 7 |
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| Day 5 |
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| Day 7 |
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| Change from Baseline (Day 5) |
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| Change from Baseline (Day 7) |
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Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 3.141 | 2-Sided | 95 | 2.953 | 3.328 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.658 | 2-Sided | 95 | 2.511 | 2.806 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.638 | 2-Sided | 95 | 2.458 | 2.817 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.754 | 2-Sided | 95 | 2.604 | 2.903 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 2.652 | 2-Sided | 95 | 2.471 | 2.832 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.703 | 2-Sided | 95 | 1.517 | 1.889 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.637 | 2-Sided | 95 | 1.410 | 1.865 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.656 | 2-Sided | 95 | 1.472 | 1.839 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.485 | 2-Sided | 95 | 1.259 | 1.711 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.713 | 2-Sided | 95 | 1.532 | 1.895 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.617 | 2-Sided | 95 | 1.397 | 1.837 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0003 | Mean Difference (Net) | -0.462 | 2-Sided | 95 | -0.766 | -0.158 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0018 | Mean Difference (Net) | -0.503 | 2-Sided | 95 | -0.867 | -0.139 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0089 | Mean Difference (Net) | -0.366 | 2-Sided | 95 | -0.670 | -0.062 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0025 | Mean Difference (Net) | -0.489 | 2-Sided | 95 | -0.851 | -0.126 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.417 | 2-Sided | 95 | -1.762 | -1.072 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.504 | 2-Sided | 95 | -1.916 | -1.091 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.464 | 2-Sided | 95 | -1.804 | -1.125 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.656 | 2-Sided | 95 | -2.065 | -1.247 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.945 | 2-Sided | 95 | 0.617 | 1.273 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.021 | 2-Sided | 95 | 0.628 | 1.413 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.041 | 2-Sided | 95 | 0.712 | 1.369 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.035 | 2-Sided | 95 | 0.644 | 1.426 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | -0.010 | 2-Sided | 95 | -0.376 | 0.355 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.020 | 2-Sided | 95 | -0.417 | 0.457 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.9999 | Mean Difference (Net) | -0.058 | 2-Sided | 95 | -0.418 | 0.303 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.9669 | Mean Difference (Net) | -0.132 | 2-Sided | 95 | -0.566 | 0.301 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.413 | 2-Sided | 95 | -1.576 | -1.251 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.754 | 2-Sided | 95 | -1.907 | -1.600 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.816 | 2-Sided | 95 | -1.972 | -1.659 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.654 | 2-Sided | 95 | -1.810 | -1.498 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.829 | 2-Sided | 95 | -1.986 | -1.673 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.184 | 2-Sided | 95 | -2.379 | -1.989 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.270 | 2-Sided | 95 | -2.468 | -2.071 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.413 | 2-Sided | 95 | -2.607 | -2.219 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.349 | 2-Sided | 95 | -2.549 | -2.149 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.227 | 2-Sided | 95 | -2.416 | -2.038 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -2.154 | 2-Sided | 95 | -2.345 | -1.962 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0552 | Mean Difference (Net) | -0.312 | 2-Sided | 95 | -0.628 | 0.004 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0055 | Mean Difference (Net) | -0.402 | 2-Sided | 95 | -0.722 | -0.083 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.3834 | Mean Difference (Net) | -0.212 | 2-Sided | 95 | -0.530 | 0.105 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0033 | Mean Difference (Net) | -0.416 | 2-Sided | 95 | -0.734 | -0.099 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.743 | 2-Sided | 95 | -1.103 | -0.382 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.857 | 2-Sided | 95 | -1.220 | -0.493 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.971 | 2-Sided | 95 | -1.327 | -0.616 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.936 | 2-Sided | 95 | -1.298 | -0.574 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0016 | Mean Difference (Net) | 0.473 | 2-Sided | 95 | 0.133 | 0.813 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0582 | Mean Difference (Net) | 0.338 | 2-Sided | 95 | -0.007 | 0.683 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.573 | 2-Sided | 95 | 0.232 | 0.914 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0745 | Mean Difference (Net) | 0.324 | 2-Sided | 95 | -0.020 | 0.668 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.043 | 2-Sided | 95 | -0.337 | 0.422 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.9759 | Mean Difference (Net) | -0.116 | 2-Sided | 95 | -0.501 | 0.268 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.7128 | Mean Difference (Net) | -0.186 | 2-Sided | 95 | -0.565 | 0.192 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.6816 | Mean Difference (Net) | -0.195 | 2-Sided | 95 | -0.582 | 0.192 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.019 | 2-Sided | 95 | -1.242 | -0.796 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.172 | 2-Sided | 95 | -1.358 | -0.986 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.196 | 2-Sided | 95 | -1.409 | -0.983 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.049 | 2-Sided | 95 | -1.239 | -0.859 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.200 | 2-Sided | 95 | -1.414 | -0.986 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.337 | 2-Sided | 95 | -1.574 | -1.099 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.345 | 2-Sided | 95 | -1.616 | -1.075 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.452 | 2-Sided | 95 | -1.685 | -1.219 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.339 | 2-Sided | 95 | -1.608 | -1.071 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.348 | 2-Sided | 95 | -1.577 | -1.118 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.227 | 2-Sided | 95 | -1.488 | -0.966 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.5646 | Mean Difference (Net) | -0.224 | 2-Sided | 95 | -0.607 | 0.160 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.8765 | Mean Difference (Net) | -0.177 | 2-Sided | 95 | -0.609 | 0.254 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.9954 | Mean Difference (Net) | -0.101 | 2-Sided | 95 | -0.488 | 0.287 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.8665 | Mean Difference (Net) | -0.181 | 2-Sided | 95 | -0.613 | 0.252 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.1165 | Mean Difference (Net) | -0.389 | 2-Sided | 95 | -0.829 | 0.052 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.3896 | Mean Difference (Net) | -0.326 | 2-Sided | 95 | -0.821 | 0.168 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0122 | Mean Difference (Net) | -0.504 | 2-Sided | 95 | -0.934 | -0.074 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.3938 | Mean Difference (Net) | -0.320 | 2-Sided | 95 | -0.807 | 0.167 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.8501 | Mean Difference (Net) | 0.176 | 2-Sided | 95 | -0.237 | 0.589 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.031 | 2-Sided | 95 | -0.435 | 0.496 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.2928 | Mean Difference (Net) | 0.299 | 2-Sided | 95 | -0.117 | 0.715 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.027 | 2-Sided | 95 | -0.439 | 0.493 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.011 | 2-Sided | 95 | -0.453 | 0.475 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.9966 | Mean Difference (Net) | -0.118 | 2-Sided | 95 | -0.640 | 0.403 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.9976 | Mean Difference (Net) | -0.104 | 2-Sided | 95 | -0.560 | 0.352 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.9976 | Mean Difference (Net) | -0.112 | 2-Sided | 95 | -0.628 | 0.404 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 181.1 | 2-Sided | 95 | 165.9 | 196.2 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 132.3 | 2-Sided | 95 | 117.2 | 147.5 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 137.3 | 2-Sided | 95 | 122.1 | 152.5 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 136.8 | 2-Sided | 95 | 122.0 | 151.7 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 150.8 | 2-Sided | 95 | 136.0 | 165.7 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 43.2 | 2-Sided | 95 | 25.1 | 61.4 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 61.7 | 2-Sided | 95 | 43.2 | 80.1 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 36.9 | 2-Sided | 95 | 18.6 | 55.1 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | 0.0002 | Mean Difference (Net) | 35.5 | 2-Sided | 95 | 16.7 | 54.3 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 38.8 | 2-Sided | 95 | 19.9 | 57.6 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 44.9 | 2-Sided | 95 | 26.0 | 63.8 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0002 | Mean Difference (Net) | -47.7 | 2-Sided | 95 | -78.0 | -17.4 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0009 | Mean Difference (Net) | -43.8 | 2-Sided | 95 | -74.1 | -13.4 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | 0.0009 | Mean Difference (Net) | -43.2 | 2-Sided | 95 | -73.2 | -13.3 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | 0.0466 | Mean Difference (Net) | -30.2 | 2-Sided | 95 | -60.2 | -0.3 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -136.8 | 2-Sided | 95 | -170.4 | -103.3 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -119.4 | 2-Sided | 95 | -153.3 | -85.5 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -143.2 | 2-Sided | 95 | -176.6 | -109.7 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -145.6 | 2-Sided | 95 | -179.7 | -111.4 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 93.6 | 2-Sided | 95 | 60.0 | 127.2 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 92.4 | 2-Sided | 95 | 58.8 | 126.1 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 98.1 | 2-Sided | 95 | 64.6 | 131.5 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 106.0 | 2-Sided | 95 | 72.5 | 139.4 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 4.5 | 2-Sided | 95 | -32.0 | 40.9 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.7714 | Mean Difference (Net) | 16.8 | 2-Sided | 95 | -20.0 | 53.5 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | -1.9 | 2-Sided | 95 | -38.3 | 34.5 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 0.9926 | Mean Difference (Net) | -9.4 | 2-Sided | 95 | -46.4 | 27.6 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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| Day 7 |
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| Day 5 |
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| Day 7 |
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| Change from Baseline (Day 5) |
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| Change from Baseline (Day 7) |
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Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 5. (mITT Population)
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.913 | 2-Sided | 95 | 1.851 | 1.976 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.467 | 2-Sided | 95 | 1.408 | 1.525 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.493 | 2-Sided | 95 | 1.434 | 1.551 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.550 | 2-Sided | 95 | 1.490 | 1.609 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.594 | 2-Sided | 95 | 1.533 | 1.654 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.557 | 2-Sided | 95 | 0.482 | 0.631 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.589 | 2-Sided | 95 | 0.514 | 0.665 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.533 | 2-Sided | 95 | 0.461 | 0.605 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.588 | 2-Sided | 95 | 0.514 | 0.662 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.580 | 2-Sided | 95 | 0.508 | 0.652 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 5. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.580 | 2-Sided | 95 | 0.507 | 0.653 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 7. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.406 | 2-Sided | 95 | -0.526 | -0.285 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.421 | 2-Sided | 95 | -0.541 | -0.300 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.323 | 2-Sided | 95 | -0.444 | -0.201 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -0.320 | 2-Sided | 95 | -0.442 | -0.198 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.315 | 2-Sided | 95 | -1.453 | -1.178 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.324 | 2-Sided | 95 | -1.463 | -1.186 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.339 | 2-Sided | 95 | -1.473 | -1.205 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | -1.325 | 2-Sided | 95 | -1.461 | -1.190 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.887 | 2-Sided | 95 | 0.757 | 1.016 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.912 | 2-Sided | 95 | 0.782 | 1.043 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 0.970 | 2-Sided | 95 | 0.839 | 1.100 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | <.0001 | Mean Difference (Net) | 1.013 | 2-Sided | 95 | 0.882 | 1.145 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.9999 | Mean Difference (Net) | -0.023 | 2-Sided | 95 | -0.168 | 0.122 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.009 | 2-Sided | 95 | -0.138 | 0.155 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) | Mixed Models Analysis | 0.9577 | Mean Difference (Net) | -0.047 | 2-Sided | 95 | -0.189 | 0.095 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population) |
| Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) | Mixed Models Analysis | 1.0000 | Mean Difference (Net) | 0.008 | 2-Sided | 95 | -0.136 | 0.152 | LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value. | Equivalence | Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population) |
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| Day 4 |
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| 0 |
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| >0 to 50 |
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