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To compare the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of 2 treatment regimens of IW-1973 tablet (40 mg per day) administered orally for 2 weeks to patients with stable type 2 diabetes mellitus and hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IW-1973 QD/QD | Experimental | On Days 1-14: IW-1973 40 mg taken once daily (QD) in morning (AM) and placebo taken QD at night (PM). |
|
| IW-1973 BID (Twice Daily)/QD | Experimental | On Days 1-7: IW-1973 20 mg taken in AM and IW-1973 20 mg taken in PM. On Days 8-14: IW-1973 40 mg taken QD in AM and placebo taken QD in PM. |
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| Placebo | Placebo Comparator | On Days 1-14: Placebo taken in AM and in PM. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IW-1973 | Drug | Oral Tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Study Baseline (Day 1 predose AM); Days 2-14: predose AM; Days 1, 2, 7, 8, 13: postdose AM 1 hour and 4 hour; Day 1: postdose AM 8 hour; Days 1, 2, 8, 13: predose PM; Days 1, 2: postdose PM 1 hour; Days 2, 3: postdose PM 4 hour; Days 15, 21, 42 | |
| Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Study Baseline (Day 1 predose AM); Days 2-14: predose AM; Days 1, 2, 7, 8, 13: postdose AM 1 hour and 4 hour; Day 1: postdose AM 8 hour; Days 1, 2, 8, 13: predose PM; Days 1, 2: postdose PM 1 hour; Days 2, 3: postdose PM 4 hour; Days 15, 21, 42 | |
| Change From Study Baseline Over Time in Supine Pulse | Study Baseline (Day 1 predose AM); Days 2-14: predose AM; Days 1, 2, 7, 8, 13: postdose AM 1 hour and 4 hour; Day 1: postdose AM 8 hour; Days 1, 2, 8, 13: predose PM; Days 1, 2: postdose PM 1 hour; Days 2, 3: postdose PM 4 hour; Days 15, 21, 42 | |
| Percentage of Participants With Postdose Supine Blood Pressure Less Than 130/80 mmHg Over Time | Baseline, Days 1-14, Day 15, 21, 42 | |
| Orthostatic Systolic Blood Pressure Over Time | An orthostatic measurement is obtained by subtracting the supine measurement from the standing measurement. | Days -1, 1, 2, 7, 8, 13: 1 and 4 hour AM; Days -1, 1, 2, 8, 13: 0 hour PM; Days -1, 1, 2: 1 hour PM; Days 1, 2, 7, 8, 13: 0 hour AM; Day 1: 8 hour AM; Days 1, 2: 4 hour PM |
| Orthostatic Diastolic Blood Pressure Over Time | An orthostatic measurement is obtained by subtracting the supine measurement from the standing measurement. | Days -1, 1, 2, 7, 8, 13: 1 and 4 hour AM; Days -1, 1, 2, 8, 13: 0 hour PM; Days -1, 1, 2: 1 hour PM; Days 1, 2, 7, 8, 13: 0 hour AM; Day 1: 8 hour AM; Days 1, 2: 4 hour PM |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProSciento, Inc. | Chula Vista | California | 91911 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39833553 | Derived | Tawa M, Nakagawa K, Ohkita M. Soluble guanylate cyclase stimulators and activators as potential antihypertensive drugs. Hypertens Res. 2025 Apr;48(4):1458-1470. doi: 10.1038/s41440-025-02110-5. Epub 2025 Jan 20. | |
| 31858186 | Derived | Hanrahan JP, Seferovic JP, Wakefield JD, Wilson PJ, Chickering JG, Jung J, Carlson KE, Zimmer DP, Frelinger AL 3rd, Michelson AD, Morrow L, Hall M, Currie MG, Milne GT, Profy AT. An exploratory, randomised, placebo-controlled, 14 day trial of the soluble guanylate cyclase stimulator praliciguat in participants with type 2 diabetes and hypertension. Diabetologia. 2020 Apr;63(4):733-743. doi: 10.1007/s00125-019-05062-x. Epub 2019 Dec 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo oral tablet taken morning (AM) and night (PM) on Days 1-14. |
| FG001 | IW-1973 40 mg Twice Dily (BID)/Once Daily (QD) | IW-1973 20 mg oral tablet taken in AM and 20 mg oral tablet taken in PM on Days 1-7. IW-1973 40 mg oral tablet taken QD in AM and placebo oral tablet taken QD in PM on Days 8-14. |
| FG002 | IW-1973 40 mg QD/QD | IW-1973 40 mg oral tablet taken QD in AM and placebo taken QD in PM on Days 1-14. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo oral tablet taken in AM and in PM on Days 1-14. |
| BG001 | IW-1973 40 mg BID/QD | IW-1973 20 mg oral tablet taken in AM and 20 mg oral tablet taken in PM on Days 1-7. IW-1973 40 mg oral tablet taken QD in AM and placebo oral tablet taken QD in PM on Days 8-14. |
| 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, Customized | Count of Participants |
| 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 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Pharmacodynamic (PD) Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | mmHg | Study Baseline (Day 1 predose AM); Days 2-14: predose AM; Days 1, 2, 7, 8, 13: postdose AM 1 hour and 4 hour; Day 1: postdose AM 8 hour; Days 1, 2, 8, 13: predose PM; Days 1, 2: postdose PM 1 hour; Days 2, 3: postdose PM 4 hour; Days 15, 21, 42 |
|
From first dose of study drug to End of Trial Visit (42 [± 3] days)
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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 | Placebo | Placebo oral tablet taken in AM and in PM on Days 1-14. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Medical Director | Cyclerion Therapeutics, Inc. | 1-857-327-8778 | info@cyclerion.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 | Mar 16, 2017 | Jul 31, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 15, 2017 | Jul 31, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000631485 | praliciguat |
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Double-Blind
| Placebo |
| Drug |
Oral Tablet |
|
| Orthostatic Pulse Over Time | An orthostatic measurement is obtained by subtracting the supine measurement from the standing measurement. | Days -1, 1, 2, 7, 8, 13: 1 and 4 hour AM; Days -1, 1, 2, 8, 13: 0 hour PM; Days -1, 1, 2: 1 hour PM; Days 1, 2, 7, 8, 13: 0 hour AM; Day 1: 8 hour AM; Days 1, 2: 4 hour PM |
| Change From Time-Matched Baseline Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 24-hour Averages of Systolic Blood Pressure | 24-hour average is the average of ABPM assessments over 24 hour intervals from the time of dosing. Time-matched baseline is the 24 hours average during Day -1. | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
| Change From Time-Matched Baseline Over Time in ABPM Daytime (12-Hour) Averages of Systolic Blood Pressure | Daytime 12-hour average is the average of ABPM assessments over daytime 12-hour intervals from the time of dosing. Time-matched baseline is the daytime 12 hours average during Day -1. | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
| Change From Time-Matched Baseline Over Time in ABPM Nighttime (12-Hour) Averages of Systolic Blood Pressure | Nighttime 12-hour average is the average of ABPM assessments over nighttime 12-hour intervals from the time of dosing. Time-matched baseline is the nighttime 12 hours average during Day -1. | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
| Change From Time-Matched Baseline Over Time in ABPM 4-hour Averages of Systolic Blood Pressure | Postdose is the average of assessments over 4-hour intervals from the time of dosing that day. Time-matched baseline is the corresponding 4-hour average on Day -1. | Time-matched baseline (Day -1), Days 1, 7, 14: 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 hours postdose |
| Change From Time-Matched Baseline Over Time in ABPM 24-hour Averages of Mean Arterial Pressure | 24-hour average is the average of ABPM assessments over 24 hour intervals from the time of dosing. Time-matched baseline is the 24 hours average during Day -1. | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
| Change From Time-Matched Baseline Over Time in ABPM Daytime (12-hour) Averages of Mean Arterial Pressure | Daytime 12-hour average is the average of ABPM assessments over daytime 12-hour intervals from the time of dosing. Time-matched baseline is the daytime 12 hours average during Day -1. | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
| Change From Time-Matched Baseline Over Time in ABPM Nighttime (12-Hour) Averages of Mean Arterial Pressure | Nighttime 12-hour average is the average of ABPM assessments over nighttime 12-hour intervals from the time of dosing. Time-matched baseline is the nighttime 12 hours average during Day -1. | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
| Change From Time-Matched Baseline Over Time in ABPM 4-hour Averages of Mean Arterial Pressure | Postdose is the average of assessments over 4-hour intervals from the time of dosing that day. Time-matched baseline is the corresponding 4-hour average on Day -1. | Time-matched baseline (Day -1), Days 1, 7, 14: 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 hours postdose |
| Change From Time-Matched Baseline Over Time in ABPM 24-hour Averages of Diastolic Blood Pressure | 24-hour average is the average of ABPM assessments over 24 hour intervals from the time of dosing. Time-matched baseline is the 24 hours average during Day -1. | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
| Change From Time-Matched Baseline Over Time in ABPM Daytime (12-hour) Averages of Diastolic Blood Pressure | Daytime 12-hour average is the average of ABPM assessments over daytime 12-hour intervals from the time of dosing. Time-matched baseline is the daytime 12 hours average during Day -1. | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
| Change From Time-Matched Baseline Over Time in ABPM Nighttime (12-Hour) Averages of Diastolic Blood Pressure | Nighttime 12-hour average is the average of ABPM assessments over nighttime 12-hour intervals from the time of dosing. Time-matched baseline is the nighttime 12 hours average during Day -1. | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
| Change From Time-Matched Baseline Over Time in ABPM 4-hour Averages of Diastolic Blood Pressure | Postdose is the average of assessments over 4-hour intervals from the time of dosing that day. Time-matched baseline is the corresponding 4-hour average on Day -1. | Time-matched baseline (Day -1), Days 1, 7, 14: 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 hours postdose |
| Change From Time-Matched Baseline Over Time in ABPM 24-hour Averages of Pulse | 24-hour average is the average of ABPM assessments over 24 hour intervals from the time of dosing. Time-matched baseline is the 24 hours average during Day -1. | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
| Change From Time-Matched Baseline Over Time in ABPM Daytime (12-hour) Averages of Pulse | Daytime 12-hour average is the average of ABPM assessments over daytime 12-hour intervals from the time of dosing. Time-matched baseline is the daytime 12 hours average during Day -1. | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
| Change From Time-Matched Baseline Over Time in ABPM Nighttime (12-Hour) Averages of Pulse | Nighttime 12-hour average is the average of ABPM assessments over nighttime 12-hour intervals from the time of dosing. Time-matched baseline is the nighttime 12 hours average during Day -1. | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
| Change From Time-Matched Baseline Over Time in ABPM 4-hour Averages of Pulse | Postdose is the average of assessments over 4-hour intervals from the time of dosing that day. Time-matched baseline is the corresponding 4-hour average on Day -1. | Time-matched baseline (Day -1), Days 1, 7, 14: 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 hours postdose |
| Change From Baseline in Reactive Hyperemia Index (RHI) on Day 13 | RHI is a measure of the extent of vessel dilatation and augmentation in vascular blood flow after a prespecified period of flow interruption. RHI is determined as the ratio of the post-to-pre- occlusion peripheral arterial tonometry amplitude of the tested (occluded) arm, divided by the post to-pre-occlusion ratio of the control arm. RHI values >1.67 indicate normal endothelial function, while values ≤1.67 indicate endothelial dysfunction. | Baseline, Day 13 predose AM |
| Post-Baseline Platelet Reactivity on Days 8 and 14: P2Y12 Reaction Units (PRU) Assay | Platelet reactivity, as measured by VerifyNow PRU assay, and presented as number of participants with < 180 PRU or ≥ 180 PRU post-baseline (Days 8 and 14), by baseline category. The VerifyNow PRU assay measures effects on platelet activation caused by inhibition of the platelet receptor, P2Y12. This receptor is activated by adenosine 5'-diphosphate (ADP) in the cascade leading to platelet aggregation but can be blocked by P2Y12 inhibitor drugs, such as clopidogrel. Blockage of this receptor diminishes platelet activation and the ability of platelets to bind to fibrinogen. VerifyNow PRU assay values < 180 units indicate impairment of platelet aggregation. | Baseline, Day 8, Day 14 |
| Post-Baseline Platelet Reactivity on Days 8 and 14: Aspirin Reaction Units (ARU) Assay | Platelet reactivity, as measured by VerifyNow ARU assay, and presented as number of participants with ≤ 549 ARU or > 549 ARU post-baseline (Days 8 and 14), by baseline category. Aspirin irreversibly inhibits cyclooxygenase 1, which converts arachidonic acid to thromboxane A2, which in turn is involved in the activation of the glycoprotein (GP)IIb/IIIa receptor necessary to initiate platelet aggregation. Impairment of platelet aggregation of the aspirin type is defined for the VerifyNow aspirin assay as values ≤ 549 ARU. | Baseline, Day 8, Day 14 |
| Change From Study Baseline Over Time in Platelet Function Assessments: PRU Assay | The VerifyNow PRU assay measures effects on platelet activation caused by inhibition of the platelet receptor, P2Y12. This receptor is activated by adenosine 5'-diphosphate (ADP) in the cascade leading to platelet aggregation but can be blocked by P2Y12 inhibitor drugs, such as clopidogrel. Blockage of this receptor diminishes platelet activation and the ability of platelets to bind to fibrinogen. VerifyNow PRU assay values <180 PRU indicate impairment of platelet aggregation. | Study Baseline (Day 1 predose), Day 8 (predose AM), Day 14 (predose AM) |
| Change From Study Baseline Over Time in Platelet Function Assessments: ARU Assay | Aspirin irreversibly inhibits cyclooxygenase 1, which converts arachidonic acid to thromboxane A2, which in turn is involved in the activation of the GPIIb IIIa receptor necessary to initiate platelet aggregation. Impairment of platelet aggregation of the aspirin type is defined for the VerifyNow aspirin assay as values ≤ 549 ARU. | Study Baseline (Day 1 predose), Day 8 (pre AM dose), Day 14 (pre AM dose) |
| Percent Change From Study Baseline Over Time in HOMA-IR in Participants Without Concomitant Use of Insulin | Blood samples were taken for fasting glucose and insulin levels. From these results, insulin resistance was then estimated using the updated homeostasis model assessment method for insulin resistance (HOMA-IR) computer algorithm. A higher HOMA-IR indicates a higher degree of insulin resistance. Typically a cutoff of HOMA-IR for identifying those with insulin resistance is 2.5. | Study baseline (defined as the last non-missing assessment before the first administration of study drug), Day 8, pre-AM dose, Day 15 |
| IW-1973 Pharmacokinetics: Area Under the Plasma Concentration Time Curve During a Dosing Interval (AUCtau) on Days 1 and 7 | Equivalent to AUC from time 0 to the last measurable concentration (AUClast), with time of last measurable concentration (Tlast)=12 hours for BID dosing and Tlast=24 hours for QD dosing. | Days 1 and 7 (AM): 1, 3, and 6 hours postdose |
| IW-1973 Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) on Days 1 and 7 | Days 1 and 7 (AM): 1, 3, and 6 hours postdose |
| IW-1973 Pharmacokinetics: Time to Cmax on Days 1 and 7 | Days 1 and 7 (AM): 1, 3, and 6 hours postdose |
| IW-1973 Pharmacokinetics: Trough Plasma Concentrations at the End of the Dosing Interval (Ctrough) on Days 1, 2, 6, 7 | Days 1 and 7: predose; Day 2 (BID AM): predose; Day 6 (BID PM/QD): predose |
| IW-1973 Pharmacokinetics: Area Under the Plasma Concentration Time Curve From Time Zero to the Last Measurable Plasma Concentration (AUClast) on Days 8 and 14 | Day 8 and 14: 1, 3, 6h (± 5 min) postdose |
| IW-1973 Pharmacokinetics: AUCtau on Day 14 | Day 14: 1, 3, 6h (± 5 min) postdose |
| IW-1973 Pharmacokinetics: Tmax on Days 8 and 14 | Day 8 and 14: 1, 3, 6h (± 5 min) postdose |
| IW-1973 Pharmacokinetics: Cmax on Days 8 and 14 | Day 8 and 14: 1, 3, 6h (± 5 min) postdose |
| IW-1973 Pharmacokinetics: Ctrough on Days 13 and 14 | Days 13 and 14: predose |
| IW-1973 Pharmacokinetics: Apparent Total Body Clearance (CL/F) on Day 14 | Day 14: 1, 3, 6h (± 5 min) postdose |
| IW-1973 Pharmacokinetics: Apparent Volume of Distribution During the Terminal Phase (Vz/F) on Day 14 | Day 14: 1, 3, 6h (± 5 min) postdose |
| IW-1973 Pharmacokinetics: Apparent Terminal Elimination Phase Half-Life (t1/2) | Day 14 (final dose) time points 12 hours, 24 hours, 7 days after final dose (Day 21), and 28 days after final dose(Day 42) |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs | An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with study treatment. An SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical events. TEAEs are defined as those AEs that started or worsened in severity after the initiation of study drug administration. AEs of clinical interest (AECI) included those related to bleeding and to hypotension. Study drug causality as assessed by the Investigator who was blinded to study drug assignment. | From first dose of study drug to End of Trial Visit (42 [± 3] days) |
| Number of Participants With Clinically Meaningful Postbaseline Laboratory Test Results | From first dose of study drug to End of Trial Visit (42 [± 3] days) |
| Number of Participants With Notable Changes in Postbaseline Blood Pressure and Heart Rate Values | Supine systolic blood pressure (SSBP): ≥ 180 mmHg and increase (↑) from baseline (BL) ≥ 30 mmHg; ≤ 90 mmHg and decrease (↓) from BL ≥ 30 mmHg. Supine diastolic blood pressure (SDBP): ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg; ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg. Supine heart rate (SHR): ≥ 110 bpm and ↑ from BL ≥ 20 bpm; ≤ 50 bpm and ↓ from BL ≥ 20 bpm. Standing systolic blood pressure (StSBP): ≥ 180 mmHg and increase (↑) from baseline (BL) ≥ 30 mmHg; ≤ 90 mmHg and decrease (↓) from BL ≥ 30 mmHg. Standing Diastolic Blood Pressure (StDBP): ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg; ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg. Standing heart rate (StHR): ≥ 110 bpm and ↑ from BL ≥ 20 bpm; ≤ 50 bpm and ↓ from BL ≥ 20 bpm. Orthostatic systolic blood pressure (SBP): ↓ > 20 mmHg from supine to standing. Orthostatic diastolic blood pressure (DBP): ↓ > 15 mmHg from supine to standing. Orthostatic HR: ↓ > 30 bpm from supine to standing. | From first dose of study drug to End of Trial Visit (42 [± 3] days) |
| Number of Participants With Clinically Significant Post-Randomization Physical Examination Findings | Physical examinations included examination and assessment of the following: general appearance, lymph nodes, skin, cardiovascular system, head, eyes, ears, nose, and throat, central nervous system, respiratory system, neck, peripheral nervous system, abdomen/liver/spleen, musculoskeletal system. | Post-randomization to End of Trial Visit (42 [± 3] days) |
| Number of Participants With Clinically Significant Postbaseline 12-Lead Electrocardiogram (ECG) Results | From first dose of study drug to End of Trial Visit (42 [± 3] days) |
| Change From Study Baseline Over Time in Estimated Glomerular Filtration Rate (eGFR) | Study Baseline, Day 15/Discharge, Day 42/End of Trial |
| BG002 | IW-1973 40 mg QD/QD | IW-1973 40 mg oral tablet taken QD in AM and placebo taken QD in PM on Days 1-14. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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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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| Percentage of Participants With Baseline Supine BP Less Than 130/80 mmHg | Number | percentage of participants |
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| OG002 | IW-1973 40 mg QD/QD | IW-1973 40 mg oral tablet taken QD in AM and placebo taken QD in PM on Days 1-14. |
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| Primary | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | mmHg | Study Baseline (Day 1 predose AM); Days 2-14: predose AM; Days 1, 2, 7, 8, 13: postdose AM 1 hour and 4 hour; Day 1: postdose AM 8 hour; Days 1, 2, 8, 13: predose PM; Days 1, 2: postdose PM 1 hour; Days 2, 3: postdose PM 4 hour; Days 15, 21, 42 |
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| Primary | Change From Study Baseline Over Time in Supine Pulse | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | bpm | Study Baseline (Day 1 predose AM); Days 2-14: predose AM; Days 1, 2, 7, 8, 13: postdose AM 1 hour and 4 hour; Day 1: postdose AM 8 hour; Days 1, 2, 8, 13: predose PM; Days 1, 2: postdose PM 1 hour; Days 2, 3: postdose PM 4 hour; Days 15, 21, 42 |
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| Primary | Percentage of Participants With Postdose Supine Blood Pressure Less Than 130/80 mmHg Over Time | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Number | percentage of participants | Baseline, Days 1-14, Day 15, 21, 42 |
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| Primary | Orthostatic Systolic Blood Pressure Over Time | An orthostatic measurement is obtained by subtracting the supine measurement from the standing measurement. | Safety Population: participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | mmHg | Days -1, 1, 2, 7, 8, 13: 1 and 4 hour AM; Days -1, 1, 2, 8, 13: 0 hour PM; Days -1, 1, 2: 1 hour PM; Days 1, 2, 7, 8, 13: 0 hour AM; Day 1: 8 hour AM; Days 1, 2: 4 hour PM |
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| Primary | Orthostatic Diastolic Blood Pressure Over Time | An orthostatic measurement is obtained by subtracting the supine measurement from the standing measurement. | Safety Population: participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | mmHg | Days -1, 1, 2, 7, 8, 13: 1 and 4 hour AM; Days -1, 1, 2, 8, 13: 0 hour PM; Days -1, 1, 2: 1 hour PM; Days 1, 2, 7, 8, 13: 0 hour AM; Day 1: 8 hour AM; Days 1, 2: 4 hour PM |
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| Primary | Orthostatic Pulse Over Time | An orthostatic measurement is obtained by subtracting the supine measurement from the standing measurement. | Safety Population: participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | bpm | Days -1, 1, 2, 7, 8, 13: 1 and 4 hour AM; Days -1, 1, 2, 8, 13: 0 hour PM; Days -1, 1, 2: 1 hour PM; Days 1, 2, 7, 8, 13: 0 hour AM; Day 1: 8 hour AM; Days 1, 2: 4 hour PM |
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| Primary | Change From Time-Matched Baseline Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 24-hour Averages of Systolic Blood Pressure | 24-hour average is the average of ABPM assessments over 24 hour intervals from the time of dosing. Time-matched baseline is the 24 hours average during Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | mmHg | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
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| Primary | Change From Time-Matched Baseline Over Time in ABPM Daytime (12-Hour) Averages of Systolic Blood Pressure | Daytime 12-hour average is the average of ABPM assessments over daytime 12-hour intervals from the time of dosing. Time-matched baseline is the daytime 12 hours average during Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | mmHg | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
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| Primary | Change From Time-Matched Baseline Over Time in ABPM Nighttime (12-Hour) Averages of Systolic Blood Pressure | Nighttime 12-hour average is the average of ABPM assessments over nighttime 12-hour intervals from the time of dosing. Time-matched baseline is the nighttime 12 hours average during Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | mmHg | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
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| Primary | Change From Time-Matched Baseline Over Time in ABPM 4-hour Averages of Systolic Blood Pressure | Postdose is the average of assessments over 4-hour intervals from the time of dosing that day. Time-matched baseline is the corresponding 4-hour average on Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | mmHg | Time-matched baseline (Day -1), Days 1, 7, 14: 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 hours postdose |
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| Primary | Change From Time-Matched Baseline Over Time in ABPM 24-hour Averages of Mean Arterial Pressure | 24-hour average is the average of ABPM assessments over 24 hour intervals from the time of dosing. Time-matched baseline is the 24 hours average during Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | mmHg | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
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| Primary | Change From Time-Matched Baseline Over Time in ABPM Daytime (12-hour) Averages of Mean Arterial Pressure | Daytime 12-hour average is the average of ABPM assessments over daytime 12-hour intervals from the time of dosing. Time-matched baseline is the daytime 12 hours average during Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | mmHg | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
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| Primary | Change From Time-Matched Baseline Over Time in ABPM Nighttime (12-Hour) Averages of Mean Arterial Pressure | Nighttime 12-hour average is the average of ABPM assessments over nighttime 12-hour intervals from the time of dosing. Time-matched baseline is the nighttime 12 hours average during Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | mmHg | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
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| Primary | Change From Time-Matched Baseline Over Time in ABPM 4-hour Averages of Mean Arterial Pressure | Postdose is the average of assessments over 4-hour intervals from the time of dosing that day. Time-matched baseline is the corresponding 4-hour average on Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | mmHg | Time-matched baseline (Day -1), Days 1, 7, 14: 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 hours postdose |
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| Primary | Change From Time-Matched Baseline Over Time in ABPM 24-hour Averages of Diastolic Blood Pressure | 24-hour average is the average of ABPM assessments over 24 hour intervals from the time of dosing. Time-matched baseline is the 24 hours average during Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | mmHg | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
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| Primary | Change From Time-Matched Baseline Over Time in ABPM Daytime (12-hour) Averages of Diastolic Blood Pressure | Daytime 12-hour average is the average of ABPM assessments over daytime 12-hour intervals from the time of dosing. Time-matched baseline is the daytime 12 hours average during Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | mmHg | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
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| Primary | Change From Time-Matched Baseline Over Time in ABPM Nighttime (12-Hour) Averages of Diastolic Blood Pressure | Nighttime 12-hour average is the average of ABPM assessments over nighttime 12-hour intervals from the time of dosing. Time-matched baseline is the nighttime 12 hours average during Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | mmHg | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
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| Primary | Change From Time-Matched Baseline Over Time in ABPM 4-hour Averages of Diastolic Blood Pressure | Postdose is the average of assessments over 4-hour intervals from the time of dosing that day. Time-matched baseline is the corresponding 4-hour average on Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | mmHg | Time-matched baseline (Day -1), Days 1, 7, 14: 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 hours postdose |
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| Primary | Change From Time-Matched Baseline Over Time in ABPM 24-hour Averages of Pulse | 24-hour average is the average of ABPM assessments over 24 hour intervals from the time of dosing. Time-matched baseline is the 24 hours average during Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | bpm | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
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| Primary | Change From Time-Matched Baseline Over Time in ABPM Daytime (12-hour) Averages of Pulse | Daytime 12-hour average is the average of ABPM assessments over daytime 12-hour intervals from the time of dosing. Time-matched baseline is the daytime 12 hours average during Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | bpm | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
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| Primary | Change From Time-Matched Baseline Over Time in ABPM Nighttime (12-Hour) Averages of Pulse | Nighttime 12-hour average is the average of ABPM assessments over nighttime 12-hour intervals from the time of dosing. Time-matched baseline is the nighttime 12 hours average during Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | bpm | Time Matched Baseline (Day -1), Days 1, 7, and 14 |
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| Primary | Change From Time-Matched Baseline Over Time in ABPM 4-hour Averages of Pulse | Postdose is the average of assessments over 4-hour intervals from the time of dosing that day. Time-matched baseline is the corresponding 4-hour average on Day -1. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. | Posted | Least Squares Mean | Standard Error | bpm | Time-matched baseline (Day -1), Days 1, 7, 14: 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 hours postdose |
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| Primary | Change From Baseline in Reactive Hyperemia Index (RHI) on Day 13 | RHI is a measure of the extent of vessel dilatation and augmentation in vascular blood flow after a prespecified period of flow interruption. RHI is determined as the ratio of the post-to-pre- occlusion peripheral arterial tonometry amplitude of the tested (occluded) arm, divided by the post to-pre-occlusion ratio of the control arm. RHI values >1.67 indicate normal endothelial function, while values ≤1.67 indicate endothelial dysfunction. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. Participants with an assessment. | Posted | Least Squares Mean | Standard Error | ratio | Baseline, Day 13 predose AM |
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| Primary | Post-Baseline Platelet Reactivity on Days 8 and 14: P2Y12 Reaction Units (PRU) Assay | Platelet reactivity, as measured by VerifyNow PRU assay, and presented as number of participants with < 180 PRU or ≥ 180 PRU post-baseline (Days 8 and 14), by baseline category. The VerifyNow PRU assay measures effects on platelet activation caused by inhibition of the platelet receptor, P2Y12. This receptor is activated by adenosine 5'-diphosphate (ADP) in the cascade leading to platelet aggregation but can be blocked by P2Y12 inhibitor drugs, such as clopidogrel. Blockage of this receptor diminishes platelet activation and the ability of platelets to bind to fibrinogen. VerifyNow PRU assay values < 180 units indicate impairment of platelet aggregation. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. Participants with a baseline (BL) and postbaseline (PBL) assessment at given time point, by specific BL category < 180 or ≥ 180 PRU. | Posted | Count of Participants | Participants | Baseline, Day 8, Day 14 |
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| Primary | Post-Baseline Platelet Reactivity on Days 8 and 14: Aspirin Reaction Units (ARU) Assay | Platelet reactivity, as measured by VerifyNow ARU assay, and presented as number of participants with ≤ 549 ARU or > 549 ARU post-baseline (Days 8 and 14), by baseline category. Aspirin irreversibly inhibits cyclooxygenase 1, which converts arachidonic acid to thromboxane A2, which in turn is involved in the activation of the glycoprotein (GP)IIb/IIIa receptor necessary to initiate platelet aggregation. Impairment of platelet aggregation of the aspirin type is defined for the VerifyNow aspirin assay as values ≤ 549 ARU. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. Participants with a baseline (BL) and postbaseline (PBL) assessment at given time point, by specific BL category (≤ 549 or > 549 ARU). | Posted | Count of Participants | Participants | Baseline, Day 8, Day 14 |
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| Primary | Change From Study Baseline Over Time in Platelet Function Assessments: PRU Assay | The VerifyNow PRU assay measures effects on platelet activation caused by inhibition of the platelet receptor, P2Y12. This receptor is activated by adenosine 5'-diphosphate (ADP) in the cascade leading to platelet aggregation but can be blocked by P2Y12 inhibitor drugs, such as clopidogrel. Blockage of this receptor diminishes platelet activation and the ability of platelets to bind to fibrinogen. VerifyNow PRU assay values <180 PRU indicate impairment of platelet aggregation. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. Participants with a baseline (BL) and postbaseline (PBL) assessment at given time point. | Posted | Mean | Standard Deviation | PRU | Study Baseline (Day 1 predose), Day 8 (predose AM), Day 14 (predose AM) |
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| Primary | Change From Study Baseline Over Time in Platelet Function Assessments: ARU Assay | Aspirin irreversibly inhibits cyclooxygenase 1, which converts arachidonic acid to thromboxane A2, which in turn is involved in the activation of the GPIIb IIIa receptor necessary to initiate platelet aggregation. Impairment of platelet aggregation of the aspirin type is defined for the VerifyNow aspirin assay as values ≤ 549 ARU. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. Participants with a baseline (BL) and postbaseline (PBL) assessment at given time point. | Posted | Mean | Standard Deviation | ARU | Study Baseline (Day 1 predose), Day 8 (pre AM dose), Day 14 (pre AM dose) |
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| Primary | Percent Change From Study Baseline Over Time in HOMA-IR in Participants Without Concomitant Use of Insulin | Blood samples were taken for fasting glucose and insulin levels. From these results, insulin resistance was then estimated using the updated homeostasis model assessment method for insulin resistance (HOMA-IR) computer algorithm. A higher HOMA-IR indicates a higher degree of insulin resistance. Typically a cutoff of HOMA-IR for identifying those with insulin resistance is 2.5. | PD Population: all participants who received at least 1 dose of study drug and had at least 1 postdose PD assessment. Participants with a baseline (BL) and postbaseline (PBL) assessment at given time point who did not use concomitant insulin. | Posted | Least Squares Mean | Standard Error | percent change | Study baseline (defined as the last non-missing assessment before the first administration of study drug), Day 8, pre-AM dose, Day 15 |
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| Primary | IW-1973 Pharmacokinetics: Area Under the Plasma Concentration Time Curve During a Dosing Interval (AUCtau) on Days 1 and 7 | Equivalent to AUC from time 0 to the last measurable concentration (AUClast), with time of last measurable concentration (Tlast)=12 hours for BID dosing and Tlast=24 hours for QD dosing. | Pharmacokinetic (PK) Population: all participants who received ≥1 dose of IW-1973 and had ≥1 postdose PK parameter assessment without events or deviations affecting the PK results. | Posted | Mean | Standard Deviation | h*ng/mL | Days 1 and 7 (AM): 1, 3, and 6 hours postdose |
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| Primary | IW-1973 Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) on Days 1 and 7 | PK Population: all participants who received ≥1 dose of IW-1973 and had ≥1 postdose PK parameter assessment without events or deviations affecting the PK results. | Posted | Mean | Standard Deviation | ng/mL | Days 1 and 7 (AM): 1, 3, and 6 hours postdose |
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| Primary | IW-1973 Pharmacokinetics: Time to Cmax on Days 1 and 7 | PK Population: all participants who received ≥1 dose of IW-1973 and had ≥1 postdose PK parameter assessment without events or deviations affecting the PK results. | Posted | Median | Full Range | hours | Days 1 and 7 (AM): 1, 3, and 6 hours postdose |
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| Primary | IW-1973 Pharmacokinetics: Trough Plasma Concentrations at the End of the Dosing Interval (Ctrough) on Days 1, 2, 6, 7 | PK Population: all participants who received ≥1 dose of IW-1973 and had ≥1 postdose PK parameter assessment without events or deviations affecting the PK results. | Posted | Mean | Standard Deviation | ng/mL | Days 1 and 7: predose; Day 2 (BID AM): predose; Day 6 (BID PM/QD): predose |
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| Primary | IW-1973 Pharmacokinetics: Area Under the Plasma Concentration Time Curve From Time Zero to the Last Measurable Plasma Concentration (AUClast) on Days 8 and 14 | PK Population: all participants who received ≥1 dose of IW-1973 and had ≥1 postdose PK parameter assessment without events or deviations affecting the PK results. | Posted | Mean | Standard Deviation | h*mg/mL | Day 8 and 14: 1, 3, 6h (± 5 min) postdose |
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| Primary | IW-1973 Pharmacokinetics: AUCtau on Day 14 | PK Population: all participants who received ≥1 dose of IW-1973 and had ≥1 postdose PK parameter assessment without events or deviations affecting the PK results. | Posted | Mean | Standard Deviation | ng/mL | Day 14: 1, 3, 6h (± 5 min) postdose |
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| Primary | IW-1973 Pharmacokinetics: Tmax on Days 8 and 14 | PK Population: all participants who received ≥1 dose of IW-1973 and had ≥1 postdose PK parameter assessment without events or deviations affecting the PK results. | Posted | Median | Full Range | hours | Day 8 and 14: 1, 3, 6h (± 5 min) postdose |
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| Primary | IW-1973 Pharmacokinetics: Cmax on Days 8 and 14 | PK Population: all participants who received ≥1 dose of IW-1973 and had ≥1 postdose PK parameter assessment without events or deviations affecting the PK results. | Posted | Mean | Standard Deviation | ng/mL | Day 8 and 14: 1, 3, 6h (± 5 min) postdose |
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| Primary | IW-1973 Pharmacokinetics: Ctrough on Days 13 and 14 | PK Population: all participants who received ≥1 dose of IW-1973 and had ≥1 postdose PK parameter assessment without events or deviations affecting the PK results. | Posted | Mean | Standard Deviation | ng/mL | Days 13 and 14: predose |
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| Primary | IW-1973 Pharmacokinetics: Apparent Total Body Clearance (CL/F) on Day 14 | PK Population: all participants who received ≥1 dose of IW-1973 and had ≥1 postdose PK parameter assessment without events or deviations affecting the PK results. | Posted | Mean | Standard Deviation | L/h | Day 14: 1, 3, 6h (± 5 min) postdose |
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| Primary | IW-1973 Pharmacokinetics: Apparent Volume of Distribution During the Terminal Phase (Vz/F) on Day 14 | PK Population: all participants who received ≥1 dose of IW-1973 and had ≥1 postdose PK parameter assessment without events or deviations affecting the PK results. | Posted | Mean | Standard Deviation | L | Day 14: 1, 3, 6h (± 5 min) postdose |
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| Primary | IW-1973 Pharmacokinetics: Apparent Terminal Elimination Phase Half-Life (t1/2) | PK Population: all participants who received ≥1 dose of IW-1973 and had ≥1 postdose PK parameter assessment without events or deviations affecting the PK results. | Posted | Mean | Standard Deviation | hours | Day 14 (final dose) time points 12 hours, 24 hours, 7 days after final dose (Day 21), and 28 days after final dose(Day 42) |
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| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs | An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with study treatment. An SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical events. TEAEs are defined as those AEs that started or worsened in severity after the initiation of study drug administration. AEs of clinical interest (AECI) included those related to bleeding and to hypotension. Study drug causality as assessed by the Investigator who was blinded to study drug assignment. | Safety Population: participants who received at least 1 dose of study drug. | Posted | Number | participants | From first dose of study drug to End of Trial Visit (42 [± 3] days) |
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| Primary | Number of Participants With Clinically Meaningful Postbaseline Laboratory Test Results | Safety Population: participants who received at least 1 dose of study drug. | Posted | Number | participants | From first dose of study drug to End of Trial Visit (42 [± 3] days) |
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| Primary | Number of Participants With Notable Changes in Postbaseline Blood Pressure and Heart Rate Values | Supine systolic blood pressure (SSBP): ≥ 180 mmHg and increase (↑) from baseline (BL) ≥ 30 mmHg; ≤ 90 mmHg and decrease (↓) from BL ≥ 30 mmHg. Supine diastolic blood pressure (SDBP): ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg; ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg. Supine heart rate (SHR): ≥ 110 bpm and ↑ from BL ≥ 20 bpm; ≤ 50 bpm and ↓ from BL ≥ 20 bpm. Standing systolic blood pressure (StSBP): ≥ 180 mmHg and increase (↑) from baseline (BL) ≥ 30 mmHg; ≤ 90 mmHg and decrease (↓) from BL ≥ 30 mmHg. Standing Diastolic Blood Pressure (StDBP): ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg; ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg. Standing heart rate (StHR): ≥ 110 bpm and ↑ from BL ≥ 20 bpm; ≤ 50 bpm and ↓ from BL ≥ 20 bpm. Orthostatic systolic blood pressure (SBP): ↓ > 20 mmHg from supine to standing. Orthostatic diastolic blood pressure (DBP): ↓ > 15 mmHg from supine to standing. Orthostatic HR: ↓ > 30 bpm from supine to standing. | Safety Population: participants who received at least 1 dose of study drug. | Posted | Number | participants | From first dose of study drug to End of Trial Visit (42 [± 3] days) |
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| Primary | Number of Participants With Clinically Significant Post-Randomization Physical Examination Findings | Physical examinations included examination and assessment of the following: general appearance, lymph nodes, skin, cardiovascular system, head, eyes, ears, nose, and throat, central nervous system, respiratory system, neck, peripheral nervous system, abdomen/liver/spleen, musculoskeletal system. | Safety Population: participants who received at least 1 dose of study drug. | Posted | Number | participants | Post-randomization to End of Trial Visit (42 [± 3] days) |
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| Primary | Number of Participants With Clinically Significant Postbaseline 12-Lead Electrocardiogram (ECG) Results | Safety Population: participants who received at least 1 dose of study drug. | Posted | Number | participants | From first dose of study drug to End of Trial Visit (42 [± 3] days) |
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| Primary | Change From Study Baseline Over Time in Estimated Glomerular Filtration Rate (eGFR) | Safety Population: participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Study Baseline, Day 15/Discharge, Day 42/End of Trial |
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| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | IW-1973 40 mg BID/QD | IW-1973 20 mg oral tablet taken in AM and 20 mg oral tablet taken in PM on Days 1-7. IW-1973 40 mg oral tablet taken QD in AM and placebo oral tablet taken QD in PM on Days 8-14. | 0 | 10 | 1 | 10 | 6 | 10 |
| EG002 | IW-1973 40 mg QD/QD | IW-1973 40 mg oral tablet taken QD in AM and placebo taken QD in PM on Days 1-14. | 0 | 10 | 0 | 10 | 8 | 10 |
| Eye irritation | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Injection site injury | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Pseudohypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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PI may publish or disclose the results of the study 24 months after final data lock provided that sponsor can review the publication prior to public release, sponsor can request removal of confidential information of sponsor (not including results of trial), and sponsor can request a publication delay in order to protect potentially patentable information. Furthermore, if a publication committee is developing an initial publication, PI is to delay disclosure until that publication is published.
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Day 1 postdose AM: 4 hour |
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| Day 1 postdose AM: 8 hour |
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| Day 1 predose PM |
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| Day 1 postdose PM: 1 hour |
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| Day 2 predose AM |
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| Day 2 postdose AM: 1 hour |
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| Day 2 postdose AM: 4 hour |
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| Day 2 predose PM |
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| Day 2 postdose PM: 1 hour |
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| Day 2 postdose PM: 4 hour |
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| Day 3 predose AM |
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| Day 3 postdose PM: 4 hour |
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| Day 4 predose AM |
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| Day 5 predose AM |
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| Day 6 predose AM |
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| Day 7 predose AM |
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| Day 7 postdose AM: 1 hour |
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| Day 7 postdose AM: 4 hour |
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| Day 8 predose AM |
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| Day 8 postdose AM: 1 hour |
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| Day 8 postdose AM: 4 hour |
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| Day 8 predose PM |
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| Day 9 predose AM |
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| Day 10 predose AM |
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| Day 11 predose AM |
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| Day 12 predose AM |
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| Day 13 predose AM |
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| Day 13 postdose AM: 1 hour |
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| Day 13 postdose AM: 4 hour |
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| Day 13 predose PM |
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| Day 14 predose AM |
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| Day 15/Discharge |
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| Day 21/Follow-Up |
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| Day 42/End of Trial |
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Day 1, post-dose AM 1 hour |
| Least squares mean difference |
| -2.0 |
| Standard Error of the Mean |
| 3.1 |
| 2-Sided |
| 95 |
| -8.4 |
| 4.5 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 1, post-dose AM 4 hour | Least squares mean difference | -2.9 | Standard Error of the Mean | 3.1 | 2-Sided | 95 | -9.2 | 3.4 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, post-dose AM 4 hour | Least squares mean difference | -7.1 | Standard Error of the Mean | 3.1 | 2-Sided | 95 | -13.5 | -0.6 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, post-dose AM 8 hour | Least squares mean difference | -5.5 | Standard Error of the Mean | 2.9 | 2-Sided | 95 | -11.5 | 0.6 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, post-dose AM 8 hour | Least squares mean difference | -4.6 | Standard Error of the Mean | 3.0 | 2-Sided | 95 | -10.8 | 1.5 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, pre-dose PM | Least squares mean difference | -3.6 | Standard Error of the Mean | 2.8 | 2-Sided | 95 | -9.4 | 2.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, pre-dose PM | Least squares mean difference | -2.1 | Standard Error of the Mean | 2.8 | 2-Sided | 95 | -8.0 | 3.7 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, post-dose PM 1 hour | Least squares mean difference | -5.0 | Standard Error of the Mean | 4.3 | 2-Sided | 95 | -13.8 | 3.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, post-dose PM 1 hour | Least squares mean difference | -2.7 | Standard Error of the Mean | 4.3 | 2-Sided | 95 | -11.7 | 6.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, pre-dose AM | Least squares mean difference | -4.4 | Standard Error of the Mean | 2.5 | 2-Sided | 95 | -9.7 | 0.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, pre-dose AM | Least squares mean difference | -3.1 | Standard Error of the Mean | 2.6 | 2-Sided | 95 | -8.5 | 2.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose AM 1 hour | Least squares mean difference | -6.7 | Standard Error of the Mean | 3.1 | 2-Sided | 95 | -13.1 | -0.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose AM 1 hour | Least squares mean difference | -5.3 | Standard Error of the Mean | 3.1 | 2-Sided | 95 | -11.8 | 1.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose AM 4 hour | Least squares mean difference | -5.4 | Standard Error of the Mean | 4.3 | 2-Sided | 95 | -14.2 | 3.5 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose AM 4 hour | Least squares mean difference | -8.5 | Standard Error of the Mean | 4.3 | 2-Sided | 95 | -17.5 | 0.5 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, pre-dose PM | Least squares mean difference | -5.7 | Standard Error of the Mean | 2.9 | 2-Sided | 95 | -11.6 | 0.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, pre-dose PM | Least squares mean difference | -4.6 | Standard Error of the Mean | 2.9 | 2-Sided | 95 | -10.6 | 1.5 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose PM 1 hour | Least squares mean difference | -0.5 | Standard Error of the Mean | 3.3 | 2-Sided | 95 | -7.4 | 6.4 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose PM 1 hour | Least squares mean difference | -2.3 | Standard Error of the Mean | 3.4 | 2-Sided | 95 | -9.3 | 4.7 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose PM 4 hour | Least squares mean difference | -2.4 | Standard Error of the Mean | 3.4 | 2-Sided | 95 | -9.4 | 4.6 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose PM 4 hour | Least squares mean difference | -1.5 | Standard Error of the Mean | 3.4 | 2-Sided | 95 | -8.7 | 5.6 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 3, pre-dose AM | Least squares mean difference | 0.2 | Standard Error of the Mean | 3.1 | 2-Sided | 95 | -6.2 | 6.7 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 3, pre-dose AM | Least squares mean difference | 0.3 | Standard Error of the Mean | 3.1 | 2-Sided | 95 | -6.2 | 6.8 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 3, post-dose PM 4 hour | Least squares mean difference | 1.5 | Standard Error of the Mean | 3.8 | 2-Sided | 95 | -6.4 | 9.4 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 3, post-dose PM 4 hour | Least squares mean difference | -1.3 | Standard Error of the Mean | 3.9 | 2-Sided | 95 | -9.3 | 6.8 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 4, pre-dose AM | Least squares mean difference | -4.3 | Standard Error of the Mean | 2.8 | 2-Sided | 95 | -10.0 | 1.4 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 4, pre-dose AM | Least squares mean difference | -4.5 | Standard Error of the Mean | 2.8 | 2-Sided | 95 | -10.3 | 1.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 5, pre-dose AM | Least squares mean difference | -2.4 | Standard Error of the Mean | 2.8 | 2-Sided | 95 | -8.2 | 3.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 5, pre-dose AM | Least squares mean difference | -7.1 | Standard Error of the Mean | 2.8 | 2-Sided | 95 | -13.0 | -1.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 6, pre-dose AM | Least squares mean difference | -2.8 | Standard Error of the Mean | 2.4 | 2-Sided | 95 | -7.7 | 2.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 6, pre-dose AM | Least squares mean difference | -4.7 | Standard Error of the Mean | 2.4 | 2-Sided | 95 | -9.7 | 0.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, pre-dose AM | Least squares mean difference | -4.1 | Standard Error of the Mean | 3.6 | 2-Sided | 95 | -11.6 | 3.5 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, pre-dose AM | Least squares mean difference | -4.3 | Standard Error of the Mean | 3.7 | 2-Sided | 95 | -12.0 | 3.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, post-dose AM 1 hour | Least squares mean difference | -4.3 | Standard Error of the Mean | 3.0 | 2-Sided | 95 | -10.6 | 1.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, post-dose AM 1 hour | Least squares mean difference | -5.7 | Standard Error of the Mean | 3.1 | 2-Sided | 95 | -12.0 | 0.7 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, post-dose AM 4 hour | Least squares mean difference | 1.0 | Standard Error of the Mean | 4.5 | 2-Sided | 95 | -8.3 | 10.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, post-dose AM 4 hour | Least squares mean difference | 0.2 | Standard Error of the Mean | 4.5 | 2-Sided | 95 | -9.2 | 9.7 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, pre-dose AM | Least squares mean difference | -4.6 | Standard Error of the Mean | 3.3 | 2-Sided | 95 | -11.5 | 2.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, pre-dose AM | Least squares mean difference | -2.9 | Standard Error of the Mean | 3.4 | 2-Sided | 95 | -9.9 | 4.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, post-dose AM 1 hour | Least squares mean difference | -9.3 | Standard Error of the Mean | 3.0 | 2-Sided | 95 | -15.5 | -3.0 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, post-dose AM 1 hour | Least squares mean difference | -8.3 | Standard Error of the Mean | 3.1 | 2-Sided | 95 | -14.6 | -1.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, post-dose AM 4 hour | Least squares mean difference | -5.3 | Standard Error of the Mean | 3.5 | 2-Sided | 95 | -12.6 | 2.0 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, post-dose AM 4 hour | Least squares mean difference | -1.3 | Standard Error of the Mean | 3.6 | 2-Sided | 95 | -8.7 | 6.1 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, pre-dose PM | Least squares mean difference | -0.7 | Standard Error of the Mean | 3.6 | 2-Sided | 95 | -8.2 | 6.7 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, pre-dose PM | Least squares mean difference | 0.3 | Standard Error of the Mean | 3.7 | 2-Sided | 95 | -7.3 | 7.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 9, pre-dose AM | Least squares mean difference | -4.9 | Standard Error of the Mean | 2.6 | 2-Sided | 95 | -10.3 | 0.6 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 9, pre-dose AM | Least squares mean difference | -2.2 | Standard Error of the Mean | 2.7 | 2-Sided | 95 | -7.7 | 3.4 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 10, pre-dose | Least squares mean difference | -3.9 | Standard Error of the Mean | 3.0 | 2-Sided | 95 | -10.0 | 2.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 10, pre-dose AM | Least squares mean difference | -5.1 | Standard Error of the Mean | 3.0 | 2-Sided | 95 | -11.4 | 1.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 11, pre-dose AM | Least squares mean difference | -8.7 | Standard Error of the Mean | 3.2 | 2-Sided | 95 | -15.2 | -2.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 11, pre-dose AM | Least squares mean difference | -5.3 | Standard Error of the Mean | 3.2 | 2-Sided | 95 | -12.0 | 1.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 12, pre-dose AM | Least squares mean difference | -2.4 | Standard Error of the Mean | 2.5 | 2-Sided | 95 | -7.6 | 2.8 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 12, pre-dose AM | Least squares mean difference | -4.5 | Standard Error of the Mean | 2.5 | 2-Sided | 95 | -9.7 | 0.8 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, pre-dose AM | Least squares mean difference | -4.9 | Standard Error of the Mean | 2.8 | 2-Sided | 95 | -10.7 | 0.8 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, pre-dose AM | Least squares mean difference | -4.6 | Standard Error of the Mean | 2.8 | 2-Sided | 95 | -10.4 | 1.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, post-dose AM 1 hour | Least squares mean difference | -9.0 | Standard Error of the Mean | 2.7 | 2-Sided | 95 | -14.6 | -3.4 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, post-dose AM 1 hour | Least squares mean difference | -8.5 | Standard Error of the Mean | 2.7 | 2-Sided | 95 | -14.2 | -2.8 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, post-dose AM 4 hour | Least squares mean difference | -6.2 | Standard Error of the Mean | 3.7 | 2-Sided | 95 | -13.8 | 1.5 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, post-dose AM 4 hour | Least squares mean difference | -6.5 | Standard Error of the Mean | 3.7 | 2-Sided | 95 | -14.3 | 1.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, pre-dose PM | Least squares mean difference | -8.0 | Standard Error of the Mean | 3.4 | 2-Sided | 95 | -15.0 | -1.0 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, pre-dose PM | Least squares mean difference | -7.1 | Standard Error of the Mean | 3.4 | 2-Sided | 95 | -14.2 | 0 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, pre-dose AM | Least squares mean difference | -1.7 | Standard Error of the Mean | 3.9 | 2-Sided | 95 | -9.8 | 6.4 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, pre-dose AM | Least squares mean difference | 0.3 | Standard Error of the Mean | 4.0 | 2-Sided | 95 | -8.0 | 8.5 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 15, Discharge | Least squares mean difference | -2.6 | Standard Error of the Mean | 3.1 | 2-Sided | 95 | -9.0 | 3.7 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 15, Discharge | Least squares mean difference | -0.7 | Standard Error of the Mean | 3.1 | 2-Sided | 95 | -7.1 | 5.8 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 21, Follow-up | Least squares mean difference | -0.8 | Standard Error of the Mean | 2.3 | 2-Sided | 95 | -5.5 | 3.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 21, Follow-up | Least squares mean difference | 0.2 | Standard Error of the Mean | 2.3 | 2-Sided | 95 | -4.6 | 4.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 42, End of trial | Least squares mean difference | 2.1 | Standard Error of the Mean | 4.2 | 2-Sided | 95 | -6.5 | 10.7 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 42, End of trial | Least squares mean difference | 0.8 | Standard Error of the Mean | 4.2 | 2-Sided | 95 | -7.9 | 9.6 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
|
| Day 1 postdose AM: 4 hour |
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| Day 1 postdose AM: 8 hour |
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| Day 1 predose PM |
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| Day 1 postdose PM: 1 hour |
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| Day 2 predose AM |
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| Day 2 postdose AM: 1 hour |
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| Day 2 postdose AM: 4 hour |
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| Day 2 predose PM |
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| Day 2 postdose PM: 1 hour |
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| Day 2 postdose PM: 4 hour |
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| Day 3 predose AM |
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| Day 3 postdose PM: 4 hour |
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| Day 4 predose AM |
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| Day 5 predose AM |
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| Day 6 predose AM |
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| Day 7 predose AM |
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| Day 7 postdose AM: 1 hour |
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| Day 7 postdose AM: 4 hour |
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| Day 8 predose AM |
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| Day 8 postdose AM: 1 hour |
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| Day 8 postdose AM: 4 hour |
|
| Day 8 predose PM |
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| Day 9 predose AM |
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| Day 10 predose AM |
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| Day 11 predose AM |
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| Day 12 predose AM |
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| Day 13 predose AM |
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| Day 13 postdose AM: 1 hour |
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| Day 13 postdose AM: 4 hour |
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| Day 13 predose PM |
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| Day 14 predose AM |
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| Day 15/Discharge |
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| Day 21/Follow-Up |
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| Day 42/End of Trial |
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Day 1, post-dose AM 1 hour |
| Least squares mean difference |
| 9.1 |
| Standard Error of the Mean |
| 5.1 |
| 2-Sided |
| 95 |
| -1.5 |
| 19.8 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 1, post-dose AM 4 hour | Least squares mean difference | 0 | Standard Error of the Mean | 4.3 | 2-Sided | 95 | -9.0 | 9.0 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, post-dose AM 4 hour | Least squares mean difference | 4.4 | Standard Error of the Mean | 4.3 | 2-Sided | 95 | -4.6 | 13.4 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, post-dose AM 8 hour | Least squares mean difference | -0.2 | Standard Error of the Mean | 3.5 | 2-Sided | 95 | -7.5 | 7.1 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, post-dose AM 8 hour | Least squares mean difference | 1.6 | Standard Error of the Mean | 3.5 | 2-Sided | 95 | -5.7 | 8.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, pre-dose PM | Least squares mean difference | 5.1 | Standard Error of the Mean | 3.4 | 2-Sided | 95 | -2.0 | 12.1 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, pre-dose PM | Least squares mean difference | 5.2 | Standard Error of the Mean | 3.4 | 2-Sided | 95 | -1.8 | 12.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, post-dose PM 1 hour | Least squares mean difference | 2.3 | Standard Error of the Mean | 3.5 | 2-Sided | 95 | -5.1 | 9.6 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, post-dose PM 1 hour | Least squares mean difference | 1.3 | Standard Error of the Mean | 3.5 | 2-Sided | 95 | -6.0 | 8.7 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, pre-dose AM | Least squares mean difference | 1.0 | Standard Error of the Mean | 2.9 | 2-Sided | 95 | -5.0 | 6.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, pre-dose AM | Least squares mean difference | 0.7 | Standard Error of the Mean | 2.9 | 2-Sided | 95 | -5.3 | 6.6 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose AM 1 hour | Least squares mean difference | 2.5 | Standard Error of the Mean | 5.1 | 2-Sided | 95 | -8.1 | 13.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose AM 1 hour | Least squares mean difference | 4.3 | Standard Error of the Mean | 5.1 | 2-Sided | 95 | -6.3 | 15.0 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose AM 4 hour | Least squares mean difference | 3.3 | Standard Error of the Mean | 3.8 | 2-Sided | 95 | -4.6 | 11.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose AM 4 hour | Least squares mean difference | 7.0 | Standard Error of the Mean | 3.8 | 2-Sided | 95 | -1.0 | 14.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, pre-dose PM | Least squares mean difference | -1.3 | Standard Error of the Mean | 3.5 | 2-Sided | 95 | -8.5 | 5.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, pre-dose PM | Least squares mean difference | -1.3 | Standard Error of the Mean | 3.5 | 2-Sided | 95 | -8.5 | 5.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose PM 1 hour | Least squares mean difference | 0.1 | Standard Error of the Mean | 4.5 | 2-Sided | 95 | -9.2 | 9.5 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose PM 1 hour | Least squares mean difference | -0.2 | Standard Error of the Mean | 4.5 | 2-Sided | 95 | -9.5 | 9.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose PM 4 hour | Least squares mean difference | 1.2 | Standard Error of the Mean | 3.0 | 2-Sided | 95 | -5.1 | 7.4 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 2, post-dose PM 4 hour | Least squares mean difference | 2.9 | Standard Error of the Mean | 3.0 | 2-Sided | 95 | -3.4 | 9.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 3, pre-dose AM | Least squares mean difference | -1.4 | Standard Error of the Mean | 3.0 | 2-Sided | 95 | -7.5 | 4.8 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 3, pre-dose AM | Least squares mean difference | -0.4 | Standard Error of the Mean | 3.0 | 2-Sided | 95 | -6.5 | 5.8 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 3, post-dose PM 4 hour | Least squares mean difference | -2.3 | Standard Error of the Mean | 3.7 | 2-Sided | 95 | -9.9 | 5.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 3, post-dose PM 4 hour | Least squares mean difference | 2.2 | Standard Error of the Mean | 3.7 | 2-Sided | 95 | -5.4 | 9.8 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 4, pre-dose AM | Least squares mean difference | 7.0 | Standard Error of the Mean | 3.3 | 2-Sided | 95 | 0.2 | 13.7 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 4, pre-dose AM | Least squares mean difference | 5.0 | Standard Error of the Mean | 3.3 | 2-Sided | 95 | -1.7 | 11.8 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 5, pre-dose AM | Least squares mean difference | 2.9 | Standard Error of the Mean | 2.9 | 2-Sided | 95 | -3.1 | 9.0 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 5, pre-dose AM | Least squares mean difference | 2.6 | Standard Error of the Mean | 2.9 | 2-Sided | 95 | -3.4 | 8.7 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 6, pre-dose AM | Least squares mean difference | 2.3 | Standard Error of the Mean | 3.7 | 2-Sided | 95 | -5.4 | 10.0 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 6, pre-dose AM | Least squares mean difference | -0.7 | Standard Error of the Mean | 3.7 | 2-Sided | 95 | -8.4 | 7.0 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, pre-dose AM | Least squares mean difference | 5.1 | Standard Error of the Mean | 3.2 | 2-Sided | 95 | -1.6 | 11.8 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, pre-dose AM | Least squares mean difference | 5.0 | Standard Error of the Mean | 3.2 | 2-Sided | 95 | -1.7 | 11.7 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, post-dose AM 1 hour | Least squares mean difference | 9.3 | Standard Error of the Mean | 5.2 | 2-Sided | 95 | -1.6 | 20.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, post-dose AM 1 hour | Least squares mean difference | 13.0 | Standard Error of the Mean | 5.3 | 2-Sided | 95 | 2.1 | 23.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, post-dose AM 4 hour | Least squares mean difference | 7.1 | Standard Error of the Mean | 3.3 | 2-Sided | 95 | 0.2 | 13.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, post-dose AM 4 hour | Least squares mean difference | 11.5 | Standard Error of the Mean | 3.3 | 2-Sided | 95 | 4.6 | 18.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, pre-dose AM | Least squares mean difference | 1.9 | Standard Error of the Mean | 3.2 | 2-Sided | 95 | -4.8 | 8.6 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, pre-dose | Least squares mean difference | 4.1 | Standard Error of the Mean | 3.2 | 2-Sided | 95 | -2.6 | 10.8 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, post-dose AM 1 hour | Least squares mean difference | 9.7 | Standard Error of the Mean | 4.7 | 2-Sided | 95 | -0.1 | 19.6 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, post-dose AM 1 hour | Least squares mean difference | 9.6 | Standard Error of the Mean | 4.7 | 2-Sided | 95 | -0.3 | 19.4 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, post-dose AM 4 hour | Least squares mean difference | 7.8 | Standard Error of the Mean | 3.7 | 2-Sided | 95 | 0 | 15.5 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, post-dose AM 4 hour | Least squares mean difference | 8.3 | Standard Error of the Mean | 3.7 | 2-Sided | 95 | 0.6 | 16.1 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, pre-dose PM | Least squares mean difference | 3.3 | Standard Error of the Mean | 4.0 | 2-Sided | 95 | -5.1 | 11.7 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 8, pre-dose PM | Least squares mean difference | 3.0 | Standard Error of the Mean | 4.0 | 2-Sided | 95 | -5.4 | 11.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 9, pre-dose AM | Least squares mean difference | 1.5 | Standard Error of the Mean | 3.7 | 2-Sided | 95 | -6.1 | 9.1 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 9, pre-dose AM | Least squares mean difference | 2.3 | Standard Error of the Mean | 3.7 | 2-Sided | 95 | -5.3 | 9.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 10, pre-dose | Least squares mean difference | 4.3 | Standard Error of the Mean | 4.0 | 2-Sided | 95 | -4.0 | 12.6 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 10, pre-dose AM | Least squares mean difference | 5.1 | Standard Error of the Mean | 4.0 | 2-Sided | 95 | -3.2 | 13.4 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 11, pre-dose AM | Least squares mean difference | -1.5 | Standard Error of the Mean | 4.6 | 2-Sided | 95 | -11.0 | 8.0 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 11, pre-dose AM | Least squares mean difference | -0.9 | Standard Error of the Mean | 4.6 | 2-Sided | 95 | -10.3 | 8.6 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 12, pre-dose AM | Least squares mean difference | 2.9 | Standard Error of the Mean | 5.1 | 2-Sided | 95 | -7.7 | 13.4 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 12, pre-dose AM | Least squares mean difference | 1.2 | Standard Error of the Mean | 5.1 | 2-Sided | 95 | -9.4 | 11.8 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, pre-dose AM | Least squares mean difference | 1.0 | Standard Error of the Mean | 4.5 | 2-Sided | 95 | -8.4 | 10.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, pre-dose AM | Least squares mean difference | 0.1 | Standard Error of the Mean | 4.5 | 2-Sided | 95 | -9.3 | 9.4 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, post-dose AM 1 hour | Least squares mean difference | 7.0 | Standard Error of the Mean | 4.0 | 2-Sided | 95 | -1.3 | 15.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, post-dose AM 1 hour | Least squares mean difference | 9.9 | Standard Error of the Mean | 4.0 | 2-Sided | 95 | 1.6 | 18.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, post-dose AM 4 hour | Least squares mean difference | 5.6 | Standard Error of the Mean | 3.2 | 2-Sided | 95 | -1.0 | 12.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, post-dose AM 4 hour | Least squares mean difference | 7.2 | Standard Error of the Mean | 3.2 | 2-Sided | 95 | 0.5 | 13.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, pre-dose PM | Least squares mean difference | -0.5 | Standard Error of the Mean | 3.8 | 2-Sided | 95 | -8.4 | 7.4 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13, pre-dose PM | Least squares mean difference | 1.9 | Standard Error of the Mean | 3.8 | 2-Sided | 95 | -6.0 | 9.9 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, pre-dose AM | Least squares mean difference | 3.9 | Standard Error of the Mean | 3.8 | 2-Sided | 95 | -4.0 | 11.8 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, pre-dose AM | Least squares mean difference | 3.3 | Standard Error of the Mean | 3.8 | 2-Sided | 95 | -4.6 | 11.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 15, Discharge | Least squares mean difference | -0.3 | Standard Error of the Mean | 3.7 | 2-Sided | 95 | -8.0 | 7.3 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 15, Discharge | Least squares mean difference | 0.5 | Standard Error of the Mean | 3.7 | 2-Sided | 95 | -7.2 | 8.1 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 21, Follow-up | Least squares mean difference | -0.7 | Standard Error of the Mean | 5.2 | 2-Sided | 95 | -11.5 | 10.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 21, Follow-up | Least squares mean difference | 6.7 | Standard Error of the Mean | 5.2 | 2-Sided | 95 | -4.1 | 17.5 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 42, End of trial | Least squares mean difference | 0.3 | Standard Error of the Mean | 4.5 | 2-Sided | 95 | -9.1 | 9.6 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 42, End of trial | Least squares mean difference | 0.8 | Standard Error of the Mean | 4.5 | 2-Sided | 95 | -8.5 | 10.2 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Title | Measurements |
|---|---|
|
| Day 2 |
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
|
| Day 8 |
|
| Day 9 |
|
| Day 10 |
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| Day 11 |
|
| Day 12 |
|
| Day 13 |
|
| Day 14 |
|
| Day 15 / Discharge |
|
| Day 21 / Follow-Up |
|
| Day 42 / End of Trial |
|
|
| Day -1, 0 hour PM |
|
| Day -1, 1 hour PM |
|
| Day 1, 0 hour AM |
|
| Day 1, 1 hour AM |
|
| Day 1, 4 hour AM |
|
| Day 1, 8 hour AM |
|
| Day 1, 0 hour PM |
|
| Day 1, 1 hour PM |
|
| Day 1, 4 hour PM |
|
| Day 2, 0 hour AM |
|
| Day 2, 1 hour AM |
|
| Day 2, 4 hour AM |
|
| Day 2, 0 Hour PM |
|
| Day 2, 1 hour PM |
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| Day 2, 4 hour PM |
|
| Day 7, 0 hour AM |
|
| Day 7, 1 hour AM |
|
| Day 7, 4 hour AM |
|
| Day 8, 0 hour AM |
|
| Day 8, 1 hour AM |
|
| Day 8, 4 hour AM |
|
| Day 8, 0 hour PM |
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| Day 13, 0 hour AM |
|
| Day 13, 1 hour AM |
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| Day 13, 4 hour AM |
|
| Day 13, 0 hour PM |
|
|
| Day -1, 0 hour PM |
|
| Day -1, 1 hour PM |
|
| Day 1, 0 hour AM |
|
| Day 1, 1 hour AM |
|
| Day 1, 4 hour AM |
|
| Day 1, 8 hour AM |
|
| Day 1, 0 hour PM |
|
| Day 1, 1 hour PM |
|
| Day 1, 4 hour PM |
|
| Day 2, 0 hour AM |
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| Day 2, 1 hour AM |
|
| Day 2, 4 hour AM |
|
| Day 2, 0 Hour PM |
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| Day 2, 1 hour PM |
|
| Day 2, 4 hour PM |
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| Day 7, 0 hour AM |
|
| Day 7, 1 hour AM |
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| Day 7, 4 hour AM |
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| Day 8, 0 hour AM |
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| Day 8, 1 hour AM |
|
| Day 8, 4 hour AM |
|
| Day 8, 0 hour PM |
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| Day 13, 0 hour AM |
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| Day 13, 1 hour AM |
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| Day 13, 4 hour AM |
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| Day 13, 0 hour PM |
|
|
| Day -1, 0 hour PM |
|
| Day -1, 1 hour PM |
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| Day 1, 0 hour AM |
|
| Day 1, 1 hour AM |
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| Day 1, 4 hour AM |
|
| Day 1, 8 hour AM |
|
| Day 1, 0 hour PM |
|
| Day 1, 1 hour PM |
|
| Day 1, 4 hour PM |
|
| Day 2, 0 hour AM |
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| Day 2, 1 hour AM |
|
| Day 2, 4 hour AM |
|
| Day 2, 0 Hour PM |
|
| Day 2, 1 hour PM |
|
| Day 2, 4 hour PM |
|
| Day 7, 0 hour AM |
|
| Day 7, 1 hour AM |
|
| Day 7, 4 hour AM |
|
| Day 8, 0 hour AM |
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| Day 8, 1 hour AM |
|
| Day 8, 4 hour AM |
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| Day 8, 0 hour PM |
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| Day 13, 0 hour AM |
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| Day 13, 1 hour AM |
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| Day 13, 4 hour AM |
|
| Day 13, 0 hour PM |
|
| Change at Day 1 |
|
| Change at Day 7 |
|
| Change at Day 14 |
|
| Day 1 | Least squares mean difference | -2.55 | Standard Error of the Mean | 2.99 | 2-Sided | 95 | -8.76 | 3.66 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 1 | Least squares mean difference | -2.93 | Standard Error of the Mean | 2.74 | 2-Sided | 95 | -8.62 | 2.75 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | -3.23 | Standard Error of the Mean | 3.44 | 2-Sided | 95 | -10.37 | 3.92 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | 0.52 | Standard Error of the Mean | 3.36 | 2-Sided | 95 | -6.46 | 7.49 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | -1.36 | Standard Error of the Mean | 3.08 | 2-Sided | 95 | -7.74 | 5.03 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -2.71 | Standard Error of the Mean | 4.21 | 2-Sided | 95 | -11.46 | 6.04 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -1.87 | Standard Error of the Mean | 3.95 | 2-Sided | 95 | -10.09 | 6.35 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -2.29 | Standard Error of the Mean | 3.67 | 2-Sided | 95 | -9.93 | 5.35 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
|
| Change at Day 7 |
|
| Change at Day 14 |
|
Day 1 |
| Least squares mean difference |
| -4.19 |
| Standard Error of the Mean |
| 3.54 |
| 2-Sided |
| 95 |
| -11.52 |
| 3.14 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 7 | Least squares mean difference | -3.82 | Standard Error of the Mean | 3.69 | 2-Sided | 95 | -11.47 | 3.83 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | 1.42 | Standard Error of the Mean | 3.63 | 2-Sided | 95 | -6.10 | 8.94 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -6.44 | Standard Error of the Mean | 4.77 | 2-Sided | 95 | -16.36 | 3.47 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -1.03 | Standard Error of the Mean | 4.52 | 2-Sided | 95 | -10.44 | 8.38 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
|
| Change at Day 7 |
|
| Change at Day 14 |
|
Day 1 |
| Least squares mean difference |
| -1.60 |
| Standard Error of the Mean |
| 3.20 |
| 2-Sided |
| 95 |
| -8.24 |
| 5.03 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 7 | Least squares mean difference | -3.12 | Standard Error of the Mean | 3.74 | 2-Sided | 95 | -10.88 | 4.65 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | -0.82 | Standard Error of the Mean | 3.68 | 2-Sided | 95 | -8.45 | 6.80 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | 0.87 | Standard Error of the Mean | 4.19 | 2-Sided | 95 | -7.84 | 9.58 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -2.98 | Standard Error of the Mean | 3.96 | 2-Sided | 95 | -11.23 | 5.26 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
|
| Time-matched baseline (Day -1): 8-12 hours |
|
| Time-matched baseline (Day -1): 12-16 hours |
|
| Time-matched baseline (Day -1): 16-20 hours |
|
| Time-matched baseline (Day -1): 20-24 hours |
|
| Day 1, 0-4 hours |
|
| Day 1, 4-8 hours |
|
| Day 1, 8-12 hours |
|
| Day 1, 12-16 hours |
|
| Day 1, 16-20 hours |
|
| Day 1, 20-24 hours |
|
| Day 7, 0-4 hours |
|
| Day 7, 4-8 hours |
|
| Day 7, 8-12 hours |
|
| Day 7, 12-16 hours |
|
| Day 7, 16-20 hours |
|
| Day 7, 20-24 hours |
|
| Day 14, 0-4 hours |
|
| Day 14, 4-8 hours |
|
| Day 14, 8-12 hours |
|
| Day 14, 12-16 hours |
|
| Day 14, 16-20 hours |
|
| Day 14, 20-24 hours |
|
Day 1, 0-4 hours |
| Least squares mean difference |
| -2.47 |
| Standard Error of the Mean |
| 3.83 |
| 2-Sided |
| 95 |
| -10.41 |
| 5.47 |
Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 1, 4-8 hours | Least squares mean difference | -8.05 | Standard Error of the Mean | 4.49 | 2-Sided | 95 | -17.36 | 1.25 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 4-8 hours | Least squares mean difference | -8.28 | Standard Error of the Mean | 4.41 | 2-Sided | 95 | -17.42 | 0.87 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 8-12 hours | Least squares mean difference | -9.34 | Standard Error of the Mean | 4.86 | 2-Sided | 95 | -19.43 | 0.74 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 8-12 hours | Least squares mean difference | -3.05 | Standard Error of the Mean | 4.77 | 2-Sided | 95 | -12.95 | 6.84 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 12-16 hours | Least squares mean difference | 3.36 | Standard Error of the Mean | 3.91 | 2-Sided | 95 | -4.74 | 11.47 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 12-16 hours | Least squares mean difference | 2.82 | Standard Error of the Mean | 3.82 | 2-Sided | 95 | -5.10 | 10.75 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 16-20 hours | Least squares mean difference | -4.43 | Standard Error of the Mean | 5.21 | 2-Sided | 95 | -15.23 | 6.37 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 16-20 hours | Least squares mean difference | -4.85 | Standard Error of the Mean | 5.21 | 2-Sided | 95 | -15.65 | 5.94 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 20-24 hours | Least squares mean difference | -0.81 | Standard Error of the Mean | 4.00 | 2-Sided | 95 | -9.10 | 7.47 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 20-24 hours | Least squares mean difference | -2.63 | Standard Error of the Mean | 3.76 | 2-Sided | 95 | -10.42 | 5.16 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 0-4 hours | Least squares mean difference | -5.54 | Standard Error of the Mean | 3.98 | 2-Sided | 95 | -13.80 | 2.72 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 0-4 hours | Least squares mean difference | -0.01 | Standard Error of the Mean | 3.97 | 2-Sided | 95 | -8.25 | 8.23 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 4-8 hours | Least squares mean difference | -2.89 | Standard Error of the Mean | 4.40 | 2-Sided | 95 | -12.01 | 6.23 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 4-8 hours | Least squares mean difference | 2.17 | Standard Error of the Mean | 4.32 | 2-Sided | 95 | -6.78 | 11.13 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 8-12 hours | Least squares mean difference | -4.23 | Standard Error of the Mean | 4.68 | 2-Sided | 95 | -13.93 | 5.47 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 8-12 hours | Least squares mean difference | 1.37 | Standard Error of the Mean | 4.59 | 2-Sided | 95 | -8.14 | 10.88 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 12-16 hours | Least squares mean difference | -0.57 | Standard Error of the Mean | 4.70 | 2-Sided | 95 | -10.32 | 9.18 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 12-16 hours | Least squares mean difference | 2.49 | Standard Error of the Mean | 4.60 | 2-Sided | 95 | -7.04 | 12.02 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 16-20 hours | Least squares mean difference | -7.89 | Standard Error of the Mean | 5.03 | 2-Sided | 95 | -18.33 | 2.55 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 16-20 hours | Least squares mean difference | -6.49 | Standard Error of the Mean | 5.03 | 2-Sided | 95 | -16.92 | 3.95 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 20-24 hours | Least squares mean difference | -3.84 | Standard Error of the Mean | 4.91 | 2-Sided | 95 | -14.03 | 6.35 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 20-24 hours | Least squares mean difference | 0.78 | Standard Error of the Mean | 4.62 | 2-Sided | 95 | -8.80 | 10.35 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 0-4 hours | Least squares mean difference | -7.13 | Standard Error of the Mean | 5.12 | 2-Sided | 95 | -17.79 | 3.53 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 0-4 hours | Least squares mean difference | 1.66 | Standard Error of the Mean | 4.93 | 2-Sided | 95 | -8.59 | 11.91 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 4-8 hours | Least squares mean difference | -6.31 | Standard Error of the Mean | 4.74 | 2-Sided | 95 | -16.17 | 3.55 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 4-8 hours | Least squares mean difference | -1.17 | Standard Error of the Mean | 4.54 | 2-Sided | 95 | -10.60 | 8.27 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 8-12 hours | Least squares mean difference | -7.01 | Standard Error of the Mean | 5.83 | 2-Sided | 95 | -19.13 | 5.11 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 8-12 hours | Least squares mean difference | -4.11 | Standard Error of the Mean | 5.50 | 2-Sided | 95 | -15.55 | 7.34 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 12-16 hours | Least squares mean difference | 1.77 | Standard Error of the Mean | 5.48 | 2-Sided | 95 | -9.63 | 13.17 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 12-16 hours | Least squares mean difference | -3.47 | Standard Error of the Mean | 5.18 | 2-Sided | 95 | -14.25 | 7.31 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 16-20 hours | Least squares mean difference | -1.73 | Standard Error of the Mean | 4.57 | 2-Sided | 95 | -11.24 | 7.77 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 16-20 hours | Least squares mean difference | -5.55 | Standard Error of the Mean | 4.46 | 2-Sided | 95 | -14.83 | 3.73 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 20-24 hours | Least squares mean difference | 1.98 | Standard Error of the Mean | 5.21 | 2-Sided | 95 | -8.85 | 12.81 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 20-24 hours | Least squares mean difference | 1.07 | Standard Error of the Mean | 4.69 | 2-Sided | 95 | -8.68 | 10.82 | Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
|
| Change at Day 1 |
|
|
| Change at Day 7 |
|
|
| Change at Day 14 |
|
|
Day 1 |
| Least squares mean difference |
| -2.39 |
| Standard Error of the Mean |
| 2.02 |
| 2-Sided |
| 95 |
| -6.59 |
| 1.80 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 1 | Least squares mean difference | -2.26 | Standard Error of the Mean | 1.86 | 2-Sided | 95 | -6.11 | 1.60 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | -3.39 | Standard Error of the Mean | 2.34 | 2-Sided | 95 | -8.25 | 1.47 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | -1.61 | Standard Error of the Mean | 2.31 | 2-Sided | 95 | -6.40 | 3.18 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | -2.50 | Standard Error of the Mean | 2.12 | 2-Sided | 95 | -6.90 | 1.90 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -4.96 | Standard Error of the Mean | 3.01 | 2-Sided | 95 | -11.22 | 1.31 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -4.50 | Standard Error of the Mean | 2.84 | 2-Sided | 95 | -10.41 | 1.40 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -4.73 | Standard Error of the Mean | 2.67 | 2-Sided | 95 | -10.27 | 0.81 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Change at Day 1 |
|
|
| Change at Day 7 |
|
|
| Change at Day 14 |
|
|
Day 1 |
| Least squares mean difference |
| -5.02 |
| Standard Error of the Mean |
| 2.82 |
| 2-Sided |
| 95 |
| -10.87 |
| 0.83 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 7 | Least squares mean difference | -4.23 | Standard Error of the Mean | 2.57 | 2-Sided | 95 | -9.55 | 1.10 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | -2.15 | Standard Error of the Mean | 2.53 | 2-Sided | 95 | -7.40 | 3.11 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -8.74 | Standard Error of the Mean | 3.31 | 2-Sided | 95 | -15.64 | -1.85 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -5.34 | Standard Error of the Mean | 3.12 | 2-Sided | 95 | -11.84 | 1.15 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Change at Day 1 |
|
|
| Change at Day 7 |
|
|
| Change at Day 14 |
|
|
Day 1 |
| Least squares mean difference |
| -0.71 |
| Standard Error of the Mean |
| 2.10 |
| 2-Sided |
| 95 |
| -5.07 |
| 3.65 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 7 | Least squares mean difference | -3.32 | Standard Error of the Mean | 2.64 | 2-Sided | 95 | -8.79 | 2.14 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | -1.74 | Standard Error of the Mean | 2.61 | 2-Sided | 95 | -7.14 | 3.67 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -1.88 | Standard Error of the Mean | 3.22 | 2-Sided | 95 | -8.58 | 4.83 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -4.30 | Standard Error of the Mean | 3.08 | 2-Sided | 95 | -10.69 | 2.10 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Time-matched baseline (Day -1): 4-8 hours |
|
|
| Time-matched baseline (Day -1): 8-12 hours |
|
|
| Time-matched baseline (Day -1): 12-16 hours |
|
|
| Time-matched baseline (Day -1): 16-20 hours |
|
|
| Time-matched baseline (Day -1): 20-24 hours |
|
|
| Day 1, 0-4 hours |
|
|
| Day 1, 4-8 hours |
|
|
| Day 1, 8-12 hours |
|
|
| Day 1, 12-16 hours |
|
|
| Day 1, 16-20 hours |
|
|
| Day 1, 20-24 hours |
|
|
| Day 7, 0-4 hours |
|
|
| Day 7, 4-8 hours |
|
|
| Day 7, 8-12 hours |
|
|
| Day 7, 12-16 hours |
|
|
| Day 7, 16-20 hours |
|
|
| Day 7, 20-24 hours |
|
|
| Day 14, 0-4 hours |
|
|
| Day 14, 4-8 hours |
|
|
| Day 14, 8-12 hours |
|
|
| Day 14, 12-16 hours |
|
|
| Day 14, 16-20 hours |
|
|
| Day 14, 20-24 hours |
|
|
Day 1, 0-4 hours |
| Least squares mean difference |
| -5.17 |
| Standard Error of the Mean |
| 3.34 |
| 2-Sided |
| 95 |
| -12.10 |
| 1.75 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 1, 4-8 hours | Least squares mean difference | -5.23 | Standard Error of the Mean | 3.69 | 2-Sided | 95 | -12.87 | 2.42 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 4-8 hours | Least squares mean difference | -8.22 | Standard Error of the Mean | 3.58 | 2-Sided | 95 | -15.64 | -0.79 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 8-12 hours | Least squares mean difference | -6.72 | Standard Error of the Mean | 3.65 | 2-Sided | 95 | -14.29 | 0.86 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 8-12 hours | Least squares mean difference | -3.14 | Standard Error of the Mean | 3.63 | 2-Sided | 95 | -10.66 | 4.38 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 12-16 hours | Least squares mean difference | 0.37 | Standard Error of the Mean | 2.45 | 2-Sided | 95 | -4.71 | 5.45 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 12-16 | Least squares mean difference | -0.02 | Standard Error of the Mean | 2.37 | 2-Sided | 95 | -4.94 | 4.91 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 16-20 hours | Least squares mean difference | -2.33 | Standard Error of the Mean | 3.73 | 2-Sided | 95 | -10.07 | 5.41 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 16-20 hours | Least squares mean difference | -2.45 | Standard Error of the Mean | 3.77 | 2-Sided | 95 | -10.26 | 5.37 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 20-24 hours | Least squares mean difference | -0.75 | Standard Error of the Mean | 2.83 | 2-Sided | 95 | -6.62 | 5.13 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 20-24 hours | Least squares mean difference | -1.13 | Standard Error of the Mean | 2.75 | 2-Sided | 95 | -6.83 | 4.58 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 0-4 hours | Least squares mean difference | -5.13 | Standard Error of the Mean | 2.70 | 2-Sided | 95 | -10.72 | 0.47 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 0-4 hours | Least squares mean difference | -3.64 | Standard Error of the Mean | 2.72 | 2-Sided | 95 | -9.29 | 2.01 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 4-8 hours | Least squares mean difference | -3.92 | Standard Error of the Mean | 3.52 | 2-Sided | 95 | -11.22 | 3.38 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 4-8 hours | Least squares mean difference | -2.46 | Standard Error of the Mean | 3.42 | 2-Sided | 95 | -9.54 | 4.63 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 8-12 hours | Least squares mean difference | -4.75 | Standard Error of the Mean | 2.96 | 2-Sided | 95 | -10.90 | 1.39 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 8-12 hours | Least squares mean difference | -1.25 | Standard Error of the Mean | 2.94 | 2-Sided | 95 | -7.35 | 4.85 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 12-16 hours | Least squares mean difference | -2.11 | Standard Error of the Mean | 3.11 | 2-Sided | 95 | -8.57 | 4.35 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 12-16 hours | Least squares mean difference | 0.05 | Standard Error of the Mean | 3.02 | 2-Sided | 95 | -6.21 | 6.31 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 16-20 hours | Least squares mean difference | -6.66 | Standard Error of the Mean | 3.65 | 2-Sided | 95 | -14.22 | 0.90 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 16-20 hours | Least squares mean difference | -6.38 | Standard Error of the Mean | 3.68 | 2-Sided | 95 | -14.01 | 1.25 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 20-24 hours | Least squares mean difference | -2.29 | Standard Error of the Mean | 3.38 | 2-Sided | 95 | -9.30 | 4.71 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 20-24 hours | Least squares mean difference | -0.17 | Standard Error of the Mean | 3.28 | 2-Sided | 95 | -6.97 | 6.64 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 0-4 hours | Least squares mean difference | -7.74 | Standard Error of the Mean | 3.51 | 2-Sided | 95 | -15.03 | -0.44 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 0-4 hours | Least squares mean difference | -3.86 | Standard Error of the Mean | 3.37 | 2-Sided | 95 | -10.88 | 3.16 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 4-8 | Least squares mean difference | -9.53 | Standard Error of the Mean | 3.16 | 2-Sided | 95 | -16.10 | -2.95 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 4-8 hours | Least squares mean difference | -5.66 | Standard Error of the Mean | 2.96 | 2-Sided | 95 | -11.82 | 0.50 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 8-12 hours | Least squares mean difference | -8.62 | Standard Error of the Mean | 4.40 | 2-Sided | 95 | -17.77 | 0.54 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 8-12 hours | Least squares mean difference | -6.05 | Standard Error of the Mean | 4.20 | 2-Sided | 95 | -14.79 | 2.69 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 12-16 hours | Least squares mean difference | -1.36 | Standard Error of the Mean | 4.40 | 2-Sided | 95 | -10.51 | 7.79 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 12-16 hours | Least squares mean difference | -4.95 | Standard Error of the Mean | 4.11 | 2-Sided | 95 | -13.50 | 3.60 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 16-20 hours | Least squares mean difference | -3.43 | Standard Error of the Mean | 3.55 | 2-Sided | 95 | -10.81 | 3.96 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 16-20 hours | Least squares mean difference | -5.38 | Standard Error of the Mean | 3.49 | 2-Sided | 95 | -12.64 | 1.89 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 20-24 hours | Least squares mean difference | -0.08 | Standard Error of the Mean | 3.59 | 2-Sided | 95 | -7.55 | 7.39 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 20-24 hours | Least squares mean difference | -1.89 | Standard Error of the Mean | 3.37 | 2-Sided | 95 | -8.89 | 5.12 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
|
| Change at Day 1 |
|
|
| Change at Day 7 |
|
|
| Change at Day 14 |
|
|
Day 1 |
| Least squares mean difference |
| -1.09 |
| Standard Error of the Mean |
| 1.63 |
| 2-Sided |
| 95 |
| -4.47 |
| 2.29 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 1 | Least squares mean difference | -0.94 | Standard Error of the Mean | 1.48 | 2-Sided | 95 | -4.02 | 2.14 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | -2.67 | Standard Error of the Mean | 1.89 | 2-Sided | 95 | -6.60 | 1.26 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | -1.84 | Standard Error of the Mean | 1.90 | 2-Sided | 95 | -5.77 | 2.10 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | -2.25 | Standard Error of the Mean | 1.72 | 2-Sided | 95 | -5.83 | 1.32 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -3.97 | Standard Error of the Mean | 2.66 | 2-Sided | 95 | -9.50 | 1.56 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -4.17 | Standard Error of the Mean | 2.57 | 2-Sided | 95 | -9.52 | 1.18 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -4.07 | Standard Error of the Mean | 2.38 | 2-Sided | 95 | -9.01 | 0.87 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Change at Day 1 |
|
|
| Change at Day 7 |
|
|
| Change at Day 14 |
|
|
Day 1 |
| Least squares mean difference |
| -3.60 |
| Standard Error of the Mean |
| 2.23 |
| 2-Sided |
| 95 |
| -8.21 |
| 1.02 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 7 | Least squares mean difference | -3.30 | Standard Error of the Mean | 2.04 | 2-Sided | 95 | -7.53 | 0.92 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | -2.01 | Standard Error of the Mean | 2.04 | 2-Sided | 95 | -6.24 | 2.23 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -7.29 | Standard Error of the Mean | 2.65 | 2-Sided | 95 | -12.80 | -1.79 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -5.10 | Standard Error of the Mean | 2.56 | 2-Sided | 95 | -10.43 | 0.23 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Change at Day 1 |
|
|
| Change at Day 7 |
|
|
| Change at Day 14 |
|
|
Day 1 |
| Least squares mean difference |
| 0.55 |
| Standard Error of the Mean |
| 1.91 |
| 2-Sided |
| 95 |
| -3.41 |
| 4.52 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 7 | Least squares mean difference | -2.54 | Standard Error of the Mean | 2.46 | 2-Sided | 95 | -7.63 | 2.56 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | -2.26 | Standard Error of the Mean | 2.46 | 2-Sided | 95 | -7.36 | 2.85 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -1.03 | Standard Error of the Mean | 3.13 | 2-Sided | 95 | -7.55 | 5.49 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | -3.68 | Standard Error of the Mean | 3.04 | 2-Sided | 95 | -10.00 | 2.65 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
|
| Time Matched Baseline (Day -1): 8-12 hours |
|
| Time Matched Baseline (Day -1): 12-16 hours |
|
| Time Matched Baseline (Day -1): 16-20 hours |
|
| Time Matched Baseline (Day -1): 20-24 hours |
|
| Day 1, 0-4 hours |
|
| Day 1, 4-8 hours |
|
| Day 1, 8-12 hours |
|
| Day 1, 12-16 hours |
|
| Day 1, 16-20 hours |
|
| Day 1, 20-24 hours |
|
| Day 7, 0-4 hours |
|
| Day 7, 4-8 hours |
|
| Day 7, 8-12 hours |
|
| Day 7, 12-16 hours |
|
| Day 7, 16-20 hours |
|
| Day 7, 20-24 hours |
|
| Day 14, 0-4 hours |
|
| Day 14, 4-8 hours |
|
| Day 14, 8-12 hours |
|
| Day 14, 12-16 hours |
|
| Day 14, 16-20 hours |
|
| Day 14, 20-24 hours |
|
Day 1, 0-4 hours |
| Least squares mean difference |
| -4.06 |
| Standard Error of the Mean |
| 2.53 |
| 2-Sided |
| 95 |
| -9.32 |
| 1.19 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 1, 4-8 hours | Least squares mean difference | -3.86 | Standard Error of the Mean | 2.73 | 2-Sided | 95 | -9.51 | 1.80 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 4-8 hours | Least squares mean difference | -4.73 | Standard Error of the Mean | 2.73 | 2-Sided | 95 | -10.40 | 0.93 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 8-12 hours | Least squares mean difference | -5.10 | Standard Error of the Mean | 3.36 | 2-Sided | 95 | -12.06 | 1.86 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 8-12 hours | Least squares mean difference | -2.96 | Standard Error of the Mean | 3.33 | 2-Sided | 95 | -9.87 | 3.96 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 12-16 hours | Least squares mean difference | 0.87 | Standard Error of the Mean | 2.69 | 2-Sided | 95 | -4.70 | 6.45 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 12-16 hours | Least squares mean difference | 0.55 | Standard Error of the Mean | 2.63 | 2-Sided | 95 | -4.90 | 6.01 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 16-20 hours | Least squares mean difference | -0.56 | Standard Error of the Mean | 3.21 | 2-Sided | 95 | -7.22 | 6.10 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 16-20 hours | Least squares mean difference | -0.47 | Standard Error of the Mean | 3.28 | 2-Sided | 95 | -7.27 | 6.34 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 20-24 hours | Least squares mean difference | 1.72 | Standard Error of the Mean | 2.40 | 2-Sided | 95 | -3.26 | 6.69 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 20-24 hours | Least squares mean difference | 0.25 | Standard Error of the Mean | 2.38 | 2-Sided | 95 | -4.69 | 5.20 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 0-4 hours | Least squares mean difference | -4.43 | Standard Error of the Mean | 1.96 | 2-Sided | 95 | -8.50 | -0.36 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 0-4 hours | Least squares mean difference | -4.17 | Standard Error of the Mean | 1.99 | 2-Sided | 95 | -8.30 | -0.03 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 4-8 hours | Least squares mean difference | -3.39 | Standard Error of the Mean | 3.10 | 2-Sided | 95 | -9.82 | 3.04 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 4-8 hours | Least squares mean difference | -1.06 | Standard Error of the Mean | 3.11 | 2-Sided | 95 | -7.51 | 5.38 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 8-12 hours | Least squares mean difference | -2.82 | Standard Error of the Mean | 2.56 | 2-Sided | 95 | -8.12 | 2.48 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 8-12 hours | Least squares mean difference | -1.36 | Standard Error of the Mean | 2.54 | 2-Sided | 95 | -6.63 | 3.91 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 12-16 hours | Least squares mean difference | -1.19 | Standard Error of the Mean | 2.97 | 2-Sided | 95 | -7.35 | 4.97 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 12-16 hours | Least squares mean difference | -1.26 | Standard Error of the Mean | 2.91 | 2-Sided | 95 | -7.30 | 4.77 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 16-20 hours | Least squares mean difference | -5.86 | Standard Error of the Mean | 3.29 | 2-Sided | 95 | -12.68 | 0.95 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 16-20 hours | Least squares mean difference | -6.20 | Standard Error of the Mean | 3.36 | 2-Sided | 95 | -13.16 | 0.76 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 20-24 hours | Least squares mean difference | -1.61 | Standard Error of the Mean | 3.02 | 2-Sided | 95 | -7.87 | 4.65 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 20-24 hours | Least squares mean difference | -0.63 | Standard Error of the Mean | 3.00 | 2-Sided | 95 | -6.85 | 5.59 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 0-4 hours | Least squares mean difference | -6.91 | Standard Error of the Mean | 2.80 | 2-Sided | 95 | -12.74 | -1.08 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 0-4 hours | Least squares mean difference | -4.04 | Standard Error of the Mean | 2.74 | 2-Sided | 95 | -9.73 | 1.66 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 4-8 hours | Least squares mean difference | -8.25 | Standard Error of the Mean | 2.57 | 2-Sided | 95 | -13.59 | -2.91 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 4-8 hours | Least squares mean difference | -5.56 | Standard Error of the Mean | 2.50 | 2-Sided | 95 | -10.76 | -0.35 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 8-12 hours | Least squares mean difference | -7.07 | Standard Error of the Mean | 3.91 | 2-Sided | 95 | -15.20 | 1.05 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 8-12 hours | Least squares mean difference | -5.85 | Standard Error of the Mean | 3.77 | 2-Sided | 95 | -13.68 | 1.98 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 12-16 hours | Least squares mean difference | -1.40 | Standard Error of the Mean | 4.20 | 2-Sided | 95 | -10.14 | 7.33 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 12-16 hours | Least squares mean difference | -5.16 | Standard Error of the Mean | 3.99 | 2-Sided | 95 | -13.46 | 3.14 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 16-20 hours | Least squares mean difference | -2.37 | Standard Error of the Mean | 3.74 | 2-Sided | 95 | -10.14 | 5.40 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 16-20 hours | Least squares mean difference | -4.51 | Standard Error of the Mean | 3.72 | 2-Sided | 95 | -12.25 | 3.23 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 20-24 hours | Least squares mean difference | -0.44 | Standard Error of the Mean | 3.44 | 2-Sided | 95 | -7.60 | 6.72 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 20-24 hours | Least squares mean difference | -1.98 | Standard Error of the Mean | 3.32 | 2-Sided | 95 | -8.88 | 4.92 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
|
| Change at Day 1 |
|
|
| Change at Day 7 |
|
|
| Change at Day 14 |
|
|
Day 1 |
| Least squares mean difference |
| 3.53 |
| Standard Error of the Mean |
| 1.58 |
| 2-Sided |
| 95 |
| 0.25 |
| 6.82 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 1 | Least squares mean difference | 3.36 | Standard Error of the Mean | 1.43 | 2-Sided | 95 | 0.40 | 6.32 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | 4.59 | Standard Error of the Mean | 1.76 | 2-Sided | 95 | 0.95 | 8.23 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | 4.49 | Standard Error of the Mean | 1.75 | 2-Sided | 95 | 0.86 | 8.12 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | 4.54 | Standard Error of the Mean | 1.58 | 2-Sided | 95 | 1.27 | 7.81 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | 2.58 | Standard Error of the Mean | 1.94 | 2-Sided | 95 | -1.45 | 6.61 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | 3.17 | Standard Error of the Mean | 1.90 | 2-Sided | 95 | -0.78 | 7.11 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | 2.87 | Standard Error of the Mean | 1.72 | 2-Sided | 95 | -0.71 | 6.45 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Change at Day 1 |
|
|
| Change at Day 7 |
|
|
| Change at Day 14 |
|
|
Day 1 |
| Least squares mean difference |
| 4.09 |
| Standard Error of the Mean |
| 2.33 |
| 2-Sided |
| 95 |
| -0.73 |
| 8.91 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 7 | Least squares mean difference | 4.56 | Standard Error of the Mean | 1.91 | 2-Sided | 95 | 0.60 | 8.51 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | 4.02 | Standard Error of the Mean | 1.91 | 2-Sided | 95 | 0.07 | 7.98 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | 3.12 | Standard Error of the Mean | 2.05 | 2-Sided | 95 | -1.15 | 7.39 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | 3.74 | Standard Error of the Mean | 2.01 | 2-Sided | 95 | -0.44 | 7.92 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Change at Day 1 |
|
|
| Change at Day 7 |
|
|
| Change at Day 14 |
|
|
Day 1 |
| Least squares mean difference |
| 2.94 |
| Standard Error of the Mean |
| 1.53 |
| 2-Sided |
| 95 |
| -0.23 |
| 6.10 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 7 | Least squares mean difference | 4.80 | Standard Error of the Mean | 2.07 | 2-Sided | 95 | 0.50 | 9.11 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7 | Least squares mean difference | 5.10 | Standard Error of the Mean | 2.05 | 2-Sided | 95 | 0.84 | 9.36 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | 1.89 | Standard Error of the Mean | 2.32 | 2-Sided | 95 | -2.93 | 6.70 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14 | Least squares mean difference | 2.55 | Standard Error of the Mean | 2.26 | 2-Sided | 95 | -2.15 | 7.25 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Time Matched Baseline (Day -1): 4-8 hours |
|
|
| Time Matched Baseline (Day -1): 8-12 hours |
|
|
| Time Matched Baseline (Day -1): 12-16 hours |
|
|
| Time Matched Baseline (Day -1): 16-20 hours |
|
|
| Time Matched Baseline (Day -1): 20-24 hours |
|
|
| Day 1, 0-4 hours |
|
|
| Day 1, 4-8 hours |
|
|
| Day 1, 8-12 hours |
|
|
| Day 1, 12-16 hours |
|
|
| Day 1, 16-20 hours |
|
|
| Day 1, 20-24 hours |
|
|
| Day 7, 0-4 hours |
|
|
| Day 7, 4-8 hours |
|
|
| Day 7, 8-12 hours |
|
|
| Day 7, 12-16 hours |
|
|
| Day 7, 16-20 hours |
|
|
| Day 7, 20-24 hours |
|
|
| Day 14, 0-4 hours |
|
|
| Day 14, 4-8 hours |
|
|
| Day 14, 8-12 hours |
|
|
| Day 14, 12-16 hours |
|
|
| Day 14, 16-20 hours |
|
|
| Day 14, 20-24 hours |
|
|
Day 1, 0-4 hours |
| Least squares mean difference |
| 6.55 |
| Standard Error of the Mean |
| 2.62 |
| 2-Sided |
| 95 |
| 1.12 |
| 11.99 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. |
| Other |
No statistical testing was performed. |
| Day 1, 4-8 hours | Least squares mean difference | -0.95 | Standard Error of the Mean | 3.49 | 2-Sided | 95 | -8.18 | 6.28 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 4-8 hours | Least squares mean difference | 1.85 | Standard Error of the Mean | 3.49 | 2-Sided | 95 | -5.39 | 9.09 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 8-12 hours | Least squares mean difference | -0.38 | Standard Error of the Mean | 2.70 | 2-Sided | 95 | -5.98 | 5.23 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 8-12 hours | Least squares mean difference | 3.10 | Standard Error of the Mean | 2.70 | 2-Sided | 95 | -2.50 | 8.70 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 12-16 hours | Least squares mean difference | 6.46 | Standard Error of the Mean | 2.14 | 2-Sided | 95 | 2.02 | 10.89 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 12-16 hours | Least squares mean difference | 5.57 | Standard Error of the Mean | 2.11 | 2-Sided | 95 | 1.19 | 9.95 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 16-20 hours | Least squares mean difference | 3.63 | Standard Error of the Mean | 1.59 | 2-Sided | 95 | 0.34 | 6.91 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 16-20 hours | Least squares mean difference | 2.41 | Standard Error of the Mean | 1.57 | 2-Sided | 95 | -0.84 | 5.66 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 20-24 hours | Least squares mean difference | 1.74 | Standard Error of the Mean | 2.23 | 2-Sided | 95 | -2.89 | 6.36 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 1, 20-24 hours | Least squares mean difference | 0.33 | Standard Error of the Mean | 2.25 | 2-Sided | 95 | -4.33 | 4.99 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 0-4 hours | Least squares mean difference | 4.36 | Standard Error of the Mean | 2.66 | 2-Sided | 95 | -1.17 | 9.88 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 0-4 hours | Least squares mean difference | 5.41 | Standard Error of the Mean | 2.68 | 2-Sided | 95 | -0.14 | 10.96 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 4-8 hours | Least squares mean difference | 4.88 | Standard Error of the Mean | 2.18 | 2-Sided | 95 | 0.36 | 9.40 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 4-8 hours | Least squares mean difference | 4.30 | Standard Error of the Mean | 2.18 | 2-Sided | 95 | -0.22 | 8.83 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 8-12 hours | Least squares mean difference | 4.04 | Standard Error of the Mean | 2.26 | 2-Sided | 95 | -0.65 | 8.72 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 8-12 hours | Least squares mean difference | 2.26 | Standard Error of the Mean | 2.26 | 2-Sided | 95 | -2.42 | 6.94 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 12-16 hours | Least squares mean difference | 6.90 | Standard Error of the Mean | 2.41 | 2-Sided | 95 | 1.91 | 11.89 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 12-16 hours | Least squares mean difference | 6.15 | Standard Error of the Mean | 2.38 | 2-Sided | 95 | 1.22 | 11.08 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 16-20 hours | Least squares mean difference | 4.99 | Standard Error of the Mean | 2.38 | 2-Sided | 95 | 0.05 | 9.93 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 16-20 hours | Least squares mean difference | 5.34 | Standard Error of the Mean | 2.36 | 2-Sided | 95 | 0.45 | 10.22 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 20-24 hours | Least squares mean difference | 1.67 | Standard Error of the Mean | 2.33 | 2-Sided | 95 | -3.17 | 6.52 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 7, 20-24 hours | Least squares mean difference | 4.03 | Standard Error of the Mean | 2.36 | 2-Sided | 95 | -0.86 | 8.92 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 0-4 hours | Least squares mean difference | 4.05 | Standard Error of the Mean | 2.51 | 2-Sided | 95 | -1.18 | 9.27 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 0-4 hours | Least squares mean difference | 3.76 | Standard Error of the Mean | 2.47 | 2-Sided | 95 | -1.38 | 8.90 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 4-8 hours | Least squares mean difference | 5.18 | Standard Error of the Mean | 3.31 | 2-Sided | 95 | -1.70 | 12.06 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 4-8 hours | Least squares mean difference | 5.61 | Standard Error of the Mean | 3.25 | 2-Sided | 95 | -1.14 | 12.37 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 8-12 hours | Least squares mean difference | -0.21 | Standard Error of the Mean | 2.47 | 2-Sided | 95 | -5.35 | 4.92 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 8-12 hours | Least squares mean difference | 1.61 | Standard Error of the Mean | 2.42 | 2-Sided | 95 | -3.42 | 6.65 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 12-16 hours | Least squares mean difference | 5.08 | Standard Error of the Mean | 3.02 | 2-Sided | 95 | -1.19 | 11.36 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 12-16 hours | Least squares mean difference | 5.30 | Standard Error of the Mean | 2.94 | 2-Sided | 95 | -0.83 | 11.42 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 16-20 hours | Least squares mean difference | 1.30 | Standard Error of the Mean | 2.56 | 2-Sided | 95 | -4.02 | 6.63 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 16-20 hours | Least squares mean difference | 2.93 | Standard Error of the Mean | 2.50 | 2-Sided | 95 | -2.26 | 8.12 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 20-24 hours | Least squares mean difference | -1.34 | Standard Error of the Mean | 2.98 | 2-Sided | 95 | -7.52 | 4.85 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 14, 20-24 hours | Least squares mean difference | -1.14 | Standard Error of the Mean | 2.94 | 2-Sided | 95 | -7.25 | 4.98 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. | Other | No statistical testing was performed. |
| Day 13 predose AM |
|
| Least squares mean difference |
| -0.105 |
| Standard Error of the Mean |
| 0.290 |
| 2-Sided |
| 95 |
| -0.708 |
| 0.498 |
Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. |
| Other |
No statistical testing was performed. |
| Least squares mean difference | -0.196 | Standard Error of the Mean | 0.255 | 2-Sided | 95 | -0.727 | 0.335 | Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Baseline: ≥180 PRU |
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| PRU Day 8: <180 BL, <180 PBL |
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| PRU Day 8: <180 BL, ≥180 PBL |
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| PRU Day 8: ≥180 BL, <180 PBL |
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| PRU Day 8: ≥180 BL, ≥180 PBL |
|
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| PRU Day 14: <180 BL, <180 PBL |
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| PRU Day 14: <180 BL, ≥180 PBL |
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| PRU Day 14: ≥180 BL, <180 PBL |
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| PRU Day 14: ≥180 BL, ≥180 PBL |
|
|
| Baseline: > 549 ARU |
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| Day 8: ≤ 549 BL, ≤ 549 PBL |
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| Day 8: ≤ 549 BL, > 549 PBL |
|
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| Day 8: > 549 BL, ≤ 549 PBL |
|
|
| Day 8: > 549 BL, > 549 PBL |
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| Day 14: ≤ 549 BL, ≤ 549 PBL |
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| Day 14: ≤ 549 BL, > 549 PBL |
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| Day 14: > 549 BL, ≤ 549 PBL |
|
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| Day 14: > 549 BL, > 549 PBL |
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|
|
| Change at Day 14 |
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| Change at Day 14 |
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|
| Day 8 |
|
|
| Day 15 |
|
|
| Day 8 | Least squares mean difference | -14.033 | Standard Error of the Mean | 26.092 | 2-Sided | 95 | -70.883 | 42.817 | Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 8 | Least squares mean difference | -18.611 | Standard Error of the Mean | 24.138 | 2-Sided | 95 | -71.204 | 33.982 | Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 15 | Least squares mean difference | -25.389 | Standard Error of the Mean | 16.885 | 2-Sided | 95 | -62.551 | 11.774 | Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 15 | Least squares mean difference | -21.176 | Standard Error of the Mean | 16.221 | 2-Sided | 95 | -56.879 | 14.527 | Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 15 | Least squares mean difference | -23.282 | Standard Error of the Mean | 14.691 | 2-Sided | 95 | -55.618 | 9.053 | Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference. | Other | No statistical testing was performed. |
| Day 7 |
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| Day 7 |
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| Day 7 |
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| Day 2 |
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| Day 6 |
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| Day 7 |
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| Title | Measurements |
|---|---|
|
| Severe TEAE |
|
| Moderate TEAE |
|
| Mild TEAE |
|
| TEAE Considered Study Drug Related |
|
| TEAE Considered Not Study Drug Related |
|
| TEAE Resulting in Study Discontinuation |
|
| TEAE Resulting in Death |
|
| AECI Related to Bleeding |
|
| AECI Related to Hypotension |
|
|
| SDBP: ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg |
|
| SDBP: ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg |
|
| SHR: ≥ 110 bpm and ↑ from BL ≥ 20 bpm |
|
| SHR: ≤ 50 bpm and ↓ from BL ≥ 20 bpm |
|
| StSBP: ≥ 180 mmHg and ↑ from BL ≥ 30 mmHg |
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| StSBP: ≤ 90 mmHg and ↓ from BL ≥ 30 mmHg |
|
| StDBP: ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg |
|
| StDBP: ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg |
|
| StHR: ≥ 120 bpm and ↑ from BL ≥ 25 bpm |
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| StHR: ≤ 50 bpm and ↓ from BL ≥ 20 bpm |
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| Orthostatic SBP: ↓ > 20 mmHg, Supine to Standing |
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| Orthostatic DBP: ↓ > 15 mmHg, Supine to Standing |
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| Orthostatic HR: ↑ > 30 bpm, Supine to Standing |
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| Day 42/End of Trial |
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