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| Name | Class |
|---|---|
| Cato Research | INDUSTRY |
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This is an open-label, 4-way crossover study designed to estimate the nicotine, glycerin, propylene glycol, menthol, formaldehyde, acetaldehyde, and acrolein levels in exhaled breath samples during use of four MarkTen® XL e-vapor products. The study will enroll approximately 32 adult e-vapor-using subjects at one site in the United States in High Point, NC.
This is an open-label, 4-way crossover study designed to estimate the nicotine, glycerin, propylene glycol, menthol, formaldehyde, acetaldehyde, and acrolein levels in exhaled breath samples during use of four MarkTen® XL e-vapor products (which are no longer manufactured or sold commercially). The study will enroll approximately 32 adult e-vapor-using (with no more that 60% of either sex). Each of the 32 subjects will provide two exhaled breath samples (10 puffs for each sample) for all four test products. Subjects will make two visits to the site, one screening visit and one 4 day in-clinic visit to provide exhalation samples for four test products (one each day for 4 days). Subjects will also use their assigned test product ad libitum for 12 hours each day after the collection of exhaled breath samples. Subjects will be randomly assigned to a test product-use schedule at Visit 2, with one test product used per day. The anticipated study duration for each subject from screening through completion of all study participation will be approximately 34 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABDC | Experimental | Subjects administered 2 menthol and and 2 non-menthol test e-vapor products: Product A (XL25F) on Day 1, Product B (XL40CB) on Day 2, Product D (XL40MB) on Day 3 and Product C (XL35WM) on Day 4 |
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| BCAD | Experimental | Subjects administered 2 menthol and and 2 non-menthol test e-vapor products: Product B (XL40CB) on Day 1, Product C (XL35WM) on Day 2, Product A (XL25F) on Day 3 and Product D (XL40MB) on Day 4 |
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| CDBA | Experimental | Subjects administered 2 menthol and and 2 non-menthol test e-vapor products: Product C (XL35WM) on Day 1 Product D (XL40MB) on Day 2, Product B (XL40CB) on Day 3 and Product A (XL25F) on Day 4 |
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| DACB | Experimental | Subjects administered 2 menthol and and 2 non-menthol test e-vapor products: Product D (XL40MB) on Day 1, Product A (XL25F) on Day 2, Product C (XL35WM) on Day 3 and Product B (XL40CB) on Day 4 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-Vapor Product A | Other | e-Vapor product XL25F |
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| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Sham Nicotine Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Measure | Description | Time Frame |
|---|---|---|
| Cartridge Weight (g) Change Summary Statistics for Sample 1 (Propylene Glycol, Glycerin, Nicotine, Menthol) by Test Product in the Exhaled-Breath Sessions | Difference in recorded weight of Sample 1, measured in grams, collected before and after product use in Exhaled Breath Sessions. Sample 1 was used to collect propylene glycol, glycerin, nicotine and menthol, and was collected approximately 1 hour before Sample 2. |
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Inclusion Criteria:
Subject candidates must satisfy the following criteria before being enrolled in the study:
provide voluntary consent to participate, as documented by the signed institutional review board (IRB)-approved informed consent form (ICF) for the study;
be between the ages of 21 and 65 years, inclusive, at the time of screening (Visit 1);
be positive for tobacco use by urine cotinine measurement (≥ 500 ng/mL) at Visit 1 (screening);
have used nicotine-containing EVPs for the 3 months before Visit 1 (screening) and use of nicotine-containing EVPs ("some days" or "every day") for the past 30 days and at least 4 out of the past 7 days before Visit 1 (screening) and at check-in for Visit 2;
have negative alcohol, amphetamines, opiates, cannabinoids, phencyclidine, and cocaine urine drug screening results (exhaled breath test for alcohol is also acceptable) at Visit 1 (screening) and at check-in for Visit 2;
if female (all females), have a negative serum pregnancy test at Visit 1 (screening) and have a negative urine pregnancy test at check-in for Visit 2;
if female and heterosexually active and of childbearing potential (e.g., not surgically sterile [i.e., bilateral tubal ligation, hysterectomy, or bilateral oophorectomy] at least 6 months before Visit 1 [screening] or at least 2 years naturally postmenopausal [follicle-stimulating hormone ≥40 IU/L at Visit 1 (screening)]), must be using one of the following forms of contraception and agree to continue using it through at least 30 days after the last study product use (if early terminated) or completion of the study:
if male and heterosexually active and capable of fathering a child (e.g., not vasectomized at least 6 months before Visit 1 [screening]), must be using a double barrier (i.e., condom with spermicide or diaphragm with spermicide) method of contraception from check-in at Visit 2 until at least 90 days after the last study product use (if early terminated) or completion of the study;
not plan to quit e-vapor use in the next 30 days;
be willing to use all assigned EVPs during the study; and
be willing and able to comply with the requirements of the study.
Exclusion Criteria:
Subjects may be excluded from the study if the subject meets any of the criteria listed below at Visit 1 (screening) and Visit 2 or at any time during the study as appropriate. Exceptions may be permitted at the discretion of the investigator in consultation with the Sponsor, providing there would be no additional risk involved for the subject. Any exceptions will be documented.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery S Edmiston, PhD | Altria Client Services | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| High Point Clinical Trials Center | High Point | North Carolina | 27265 | United States |
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| Label | URL |
|---|---|
| Poster presentation at 2018 Society for Research in Nicotine and Tobacco annual meeting entitled: Exhaled Breath Levels of Selected Constituents From Controlled Use of MarkTen® e-Vapor Products in Adult e-Vapor Users | View source |
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35 subjects (including alternates) used at least one test product during the Day -1 Trial. One subject discontinued from the study before randomization; 2 alternates were discontinued prior to randomization once the enrollment goal of 32 subjects was met. Therefore, a total of 32 subjects were randomized into the study. The 3 subjects who were discontinued prior to randomization constitute the "Day -1 Trial" group and are included in the Safety Population for AE reporting, and Baseline data.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABDC | Subjects administered 2 menthol and 2 non-menthol test e-vapor products: Product A (XL25F) on Day 1, Product B (XL40CB) on Day 2, Product D (XL40MB) on Day 3 and Product C (XL35WM) on Day 4 |
| FG001 | BCAD | Subjects administered 2 menthol and 2 non-menthol test e-vapor products: Product B (XL40CB) on Day 1, Product C (XL35WM) on Day 2, Product A (XL25F) on Day 3 and Product D (XL40MB) on Day 4 |
| FG002 | CDBA | Subjects administered 2 menthol and 2 non-menthol test e-vapor products: Product C (XL35WM) on Day 1 Product D (XL40MB) on Day 2, Product B (XL40CB) on Day 3 and Product A (XL25F) on Day 4 |
| FG003 | DACB | Subjects administered 2 menthol and 2 non-menthol test e-vapor products: Product D (XL40MB) on Day 1, Product A (XL25F) on Day 2, Product C (XL35WM) on Day 3 and Product B (XL40CB) on Day 4 |
| FG004 | Day -1 Trial | Subjects who used at least one test product during the Visit 2, Day -1 product trial, but were not subsequently randomized. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ABDC | Subjects administered 2 menthol and and 2 non-menthol test e-vapor products: Product A (XL25F) on Day 1, Product B (XL40CB) on Day 2, Product D (XL40MB) on Day 3 and Product C (XL35WM) on Day 4 |
| BG001 | BCAD |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Nicotine Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
Adverse Event (AE) data collected for entire study duration: approximately 34 days from Visit 1 (screening) through End of Study for each individual subject.
Review of adverse events conducted by study staff at each study visit and documented in both source documentation and electronic Case Report Form.
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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 | e-Vapor Product A | Product XL25F = Test e-vapor product (EVP) (formerly marketed by Nu Mark LLC as MarkTen® XL Fusion [2.5% nicotine by weight {NBW}]) e-Vapor Product A: e-Vapor product |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
In this study, a cut off of greater than 50% of the samples too low to be detected was used to determine which analytes would be analyzed with a mixed model. Exhaled acetaldehyde and acrolein amounts were not detectable in 100% of subjects; therefore the differences in concentrations between sham and product trials for these analytes were not analyzed as intended in the statistical analysis plan.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffery Edmiston, Functional Director Clinical Research | Altria | 8043352366 | Jeffery.S.Edmiston@altria.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 10, 2017 | Sep 20, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2017 | Sep 20, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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This is an open-label, 4-way crossover study designed to estimate the nicotine, glycerin, propylene glycol, menthol, formaldehyde, acetaldehyde, and acrolein levels in exhaled breath samples during use of four MarkTen® XL e-vapor products.
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| e-Vapor Product B | Other | e-Vapor product XL40CB |
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| e-Vapor Product C | Other | e-Vapor product XL35WM |
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| e-Vapor Product D | Other | e-Vapor product XL40MB |
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| Total Sham-Corrected Nicotine Summary Statistics by Test Product Group | Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery & empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge & inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Glycerin Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Sham Glycerin Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Total Sham-Corrected Glycerin Summary Statistics by Test Product Group | Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery & empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge & inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Menthol Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Sham Menthol Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Total Sham-Corrected Menthol Summary Statistics by Test Product Group | Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery & empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge & inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Propylene Glycol Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Sham Propylene Glycol Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Total Sham-Corrected Propylene Glycol Summary Statistics by Test Product Group | Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery & empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge & inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Formaldehyde Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Sham Formaldehyde Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Total Sham-Corrected Formaldehyde Summary Statistics by Test Product Group | Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery & empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge & inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Acetaldehyde Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Sham Acetaldehyde Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Total Sham-Corrected Acetaldehyde Summary Statistics by Test Product Group | Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery & empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge & inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Acrolein Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Sham Acrolein Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Total Sham-Corrected Acrolein Summary Statistics by Test Product Group | Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery & empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge & inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Samples collected during the approximately 1 hour controlled exhaled breath product use session on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Cartridge Weight (g) Change Summary Statistics for Sample 2 (Formaldehyde, Acetaldehyde, Acrolein) by Test Product in the Exhaled-Breath Sessions | Difference in recorded weight of Sample 2, measured in grams, collected before and after product use in Exhaled Breath Sessions, Sample 2 was used to collect formaldehyde, acetaldehyde and acrolein, and was collected approximately 1 hour after Sample 1. | Samples collected during the approximately 1 hour controlled exhaled breath product use session on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
| Summary Statistics of Total Cartridge Weight Change by Test Product, Per Subject, During the Ad Libitum-Use Sessions | Difference in recorded weight (measured in grams) by test product, per subject, collected before and after product use in ad libitum sessions | Samples were collected over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
| Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Change in cartridge weight (measured in grams) as measured before and after a 12-hour ad-libitum use session of the product. | Samples were collected over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
| Summary Statistics of Puff Count by Test Product During the Ad Libitum-Use Sessions | Number of puffs, by test product, per subject, taken during 12-hour ad libitum product use session | Data was collected over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
| Average Puff Duration by Test Product During the Ad Libitum-Use Sessions | Seconds per puff taken, by test product, per subject, during 12-hour ad libitum product use session | Data was collected over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
| Total Puff Duration by Test Product During the Ad Libitum-Use Sessions | Total seconds puffing by test product, per subject, taken during 12-hour ad libitum product use session | Data was collected over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
| Total Cartridges Used by Test Product During the Ad Libitum-Use Sessions | Total cartridges used by test product, per subject, taken during 12-hour ad libitum product use session | Data was collected over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
| Summary of Binary VAS-Derived Categorical "Use Product Again Questionnaire" Scores by Test Product | Visual Analog Scale (VAS) measuring self-reported response to "Use the product again" questionnaire was collected after each product use session. The questionnaire consists of a single question ("If given the opportunity, I would want to use this product again"). Participants indicated their willingness to use the product again by pointing to a line measuring 100mm, with scores measured from left to right and ranging between 0 to 100 mm. Scores closer to the right, and thus higher on the scale, indicated a greater willingness to utilize the product again. Raw scores were converted to a binary score as follows: VAS scores < 50 mm ≈ unwillingness to use the product again, and VAS scores ≥ 50 mm ≈ willingness to use product again. | Data was collected at the end of the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
| Summary of Ordinal VAS-Derived Categorical "Use Product Again Questionnaire" Scores by Test Product | Visual Analog Scale (VAS) measuring self-reported response to willingness to use study product again. Questionnaire was collected after each product use session. Questionnaire consists of a single question ("If given the opportunity, I would want to use this product again") with VAS response range from "Definitely Would Not" to "Don't Care" to "Definitely Would". Participants indicated their willingness to use the product again by pointing to a line measuring 100mm, with scores measured from left to right and ranging between 0 to 100 mm. Scores closer to the right, and thus higher on the scale, indicated a greater willingness to utilize the product again. The raw scores were then converted to a binary, "unwilling" vs. "willing" to use response. Additionally, a 3-level ordinal response was computed using "unwilling" (VAS < 50 mm), "don't care" (VAS = 50 mm), and "willing" (VAS > 50 mm). | Data was collected at the end of the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
| Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Puff Count by Test Product (Pooled Over Cartridges) during 12-hour ad-libitum-use session of the product. | Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
| Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Average puff duration (measured in seconds) by Test Product (Pooled Over Cartridges) during 12-hour ad-libitum-use session of the product. | Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
| Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Total Puff Duration (measured in seconds) by Test Product (pooled over cartridges) during 12-hour ad-libitum-use session of the product. | Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
| Total Weight Change by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | Change in cartridge weight (measured in grams) as measured before and after a 12-hour ad-libitum use session of the product. | Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
| Average Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | Average puff duration (measured in seconds) by Test Product, per completed cartridge, during a 12-hour ad-libitum use session of the product. | Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
| Puff Count by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | Puff count by Test Product, per completed cartridge, during a 12-hour ad-libitum use session of the product. | Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
| Total Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | Total Puff Duration (measured in seconds) by Test Product, per completed cartridge, during a 12-hour ad-libitum use session of the product. | Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
| Alternates |
|
Subjects administered 2 menthol and and 2 non-menthol test e-vapor products:
Product B (XL40CB) on Day 1, Product C (XL35WM) on Day 2, Product A (XL25F) on Day 3 and Product D (XL40MB) on Day 4
| BG002 | CDBA | Subjects administered 2 menthol and and 2 non-menthol test e-vapor products: Product C (XL35WM) on Day 1 Product D (XL40MB) on Day 2, Product B (XL40CB) on Day 3 and Product A (XL25F) on Day 4 |
| BG003 | DACB | Subjects administered 2 menthol and and 2 non-menthol test e-vapor products: Product D (XL40MB) on Day 1, Product A (XL25F) on Day 2, Product C (XL35WM) on Day 3 and Product B (XL40CB) on Day 4 |
| BG004 | Day-1 Trial | Subjects who used at least one test product during the Visit 2, Day -1 product trial, but were not subsequently randomized |
| BG005 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Annual Household Income | Subject responses to Demographics survey question "What was your annual household income from all sources over the past year?" | Count of Participants | Participants |
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| Education | Subject responses to Demographics survey question "What is the highest grade or year of school you completed?" | Count of Participants | Participants |
|
| Height | Summary of subject height (in cm) by Sequence | Mean | Standard Deviation | cm |
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| Weight | Summary of subject weight (in kg) by Sequence | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Summary of Subject BMI (in kg/m2) by Sequence | Mean | Standard Deviation | kg/m² |
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| Employment Status | Count of Participants | Participants |
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| Military Experience | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
|
| Sexual Identity | Count of Participants | Participants |
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| Previous Cigarette Usage | Subject responses were collected from the product-use survey question "Ever smoked Cigarettes?" | Count of Participants | Participants |
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| 100 or more lifetime cigarettes | Subject responses were collected from the product-use survey question "Smoked >= 100 cigarettes in lifetime" | Count of Participants | Participants |
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| Smoke on a regular basis | Subject responses were collected from the product-use survey question "Ever smoked on regular basis" | Count of Participants | Participants |
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| Length of Consistent Smoking | Subject responses were collected from the product-use survey question "How long did you smoke consistently?" | Not all participants were asked to respond due to skip logics. | Mean | Standard Deviation | Years |
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| Smoking Frequency in past 30 days | Subject responses were collected from the product-use survey question "How often did you smoke in the past 30 days?" | Count of Participants | Participants |
|
| Daily Cigarette Use | Subject responses were collected from the product-use survey question "In the past 30 days how many cigarettes did you smoke per day?". | Based on each subject's smoking history, not all subjects were required to answer this question. | Mean | Standard Deviation | number of cigarettes |
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| Menthol Cigarettes Regularly | Subject responses were collected from the product-use survey question "Are the cigarettes that you regularly smoke, menthol?" | Count of Participants | Participants |
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| Daily Smoking | Subject responses were collected from the product-use survey question "Have you smoked daily (or nearly so) during the last year?" | Count of Participants | Participants |
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| Previously Quit Smoking | Subject responses were collected from the product-use survey question "Have you quit smoking for at least 1 day during the last year?" | Count of Participants | Participants |
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| Quit Smoking Completely | Subject responses were collected from the product-use survey question "Have you quit smoking completely?" | Count of Participants | Participants |
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| Current Quit Smoking Duration | Subject responses were collected from the product-use survey question "How long have you quit smoking (currently)?" | Count of Participants | Participants |
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| Previous E-Cigarette Usage | Subject responses were collected from the product-use survey question "Have you ever tried an e-cigarette?" | Count of Participants | Participants |
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| Type of e-Cigarette and e-Vapor Product Use | Subject responses were collected from the product-use survey question "What types of e-cigarette and e-vapor products do you currently use?". Type 1 = Disposable e-cigarettes; Type 2 = Rechargeable e-cigarettes with pre-filled cartridges that are replaced; Type 3 = Any type of rechargeable e-cigarette or e-vapor product that you refill with e-liquid | Count of Participants | Participants |
|
| Number of Days of e-cigarette Use in Past Week | Subject responses were collected from the product-use survey question "In the last week how many days did you use an e-cigarette?" | Mean | Standard Deviation | days |
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| 30 Day Disposable E-Cigarette/Cartridge Count | Subject responses were collected from the product-use survey question "In the last 30 days how many disposable e-cigarettes or cartridges did you use?" | Mean | Standard Deviation | E-Cigarettes/Cartridges |
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| Milliliters of E-Liquid/day in last 30 Days | Subject responses were collected from the product-use survey question "In the last 30 days how many mls e-liquid did you use per day?" | Mean | Standard Deviation | ml/day |
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| e-Cigarette Length of Use | Subject responses were collected from the product-use survey question "How many months have you been using e-cigarettes?" | Mean | Standard Deviation | months |
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| e-Cigarette Use Frequency in Past 30 Days | Subject responses were collected from the product-use survey question "How often did you use e-cigarettes in the past 30 days?" | Count of Participants | Participants |
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| Quit E-Cigarettes in Last Year | Subject responses were collected from the product-use survey question "Have you quit using e-cigarettes in the last 12 months?" | Count of Participants | Participants |
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| Plan to Quit Smoking | Subject responses were collected from the product-use survey question "Do you plan to quit smoking in the next 30 days?" | Count of Participants | Participants |
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| Plan to Quit E-Cigarettes | Subject responses were collected from the product-use survey question "Are you planning to quit using e-cigarettes in the next 30 days?" | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | e-Vapor Product A | Product XL25F = Test e-vapor product (EVP) (formerly marketed by Nu Mark LLC as MarkTen® XL Fusion [2.5% nicotine by weight {NBW}]) e-Vapor Product A: e-Vapor product |
| OG001 | e-Vapor Product B | Product XL40CB = Test EVP (formerly marketed by Nu Mark LLC as MarkTen® XL Bold Classic [4.0% NBW]) e-Vapor Product B: e-Vapor product |
| OG002 | e-Vapor Product C | Product XL35WM = Test EVP (formerly marketed by Nu Mark LLC as MarkTen® XL Winter Mint [3.5% NBW]) e-Vapor Product C: e-Vapor product |
| OG003 | e-Vapor Product D | Product XL40MB = Test EVP (formerly marketed by Nu Mark LLC as MarkTen® XL Bold Menthol [4.0% NBW]) e-Vapor Product D: e-Vapor product |
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| Primary | Sham Nicotine Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Total Sham-Corrected Nicotine Summary Statistics by Test Product Group | Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery & empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge & inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Glycerin Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Sham Glycerin Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Total Sham-Corrected Glycerin Summary Statistics by Test Product Group | Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery & empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge & inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Menthol Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Sham Menthol Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Total Sham-Corrected Menthol Summary Statistics by Test Product Group | Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery & empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge & inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Propylene Glycol Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Sham Propylene Glycol Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Total Sham-Corrected Propylene Glycol Summary Statistics by Test Product Group | Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery & empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge & inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Formaldehyde Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Sham Formaldehyde Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Total Sham-Corrected Formaldehyde Summary Statistics by Test Product Group | Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery & empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge & inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Acetaldehyde Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Sham Acetaldehyde Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Total Sham-Corrected Acetaldehyde Summary Statistics by Test Product Group | Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery & empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge & inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Deviation | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Acrolein Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Error | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Sham Acrolein Residue Summary Statistics by Test-Product Group | Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Error | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Primary | Total Sham-Corrected Acrolein Summary Statistics by Test Product Group | Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery & empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge & inactive battery [sham condition] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over ~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values. | Posted | Mean | Standard Error | Micrograms | Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Secondary | Cartridge Weight (g) Change Summary Statistics for Sample 1 (Propylene Glycol, Glycerin, Nicotine, Menthol) by Test Product in the Exhaled-Breath Sessions | Difference in recorded weight of Sample 1, measured in grams, collected before and after product use in Exhaled Breath Sessions. Sample 1 was used to collect propylene glycol, glycerin, nicotine and menthol, and was collected approximately 1 hour before Sample 2. | Posted | Mean | Standard Deviation | Grams | Samples collected during the approximately 1 hour controlled exhaled breath product use session on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Secondary | Cartridge Weight (g) Change Summary Statistics for Sample 2 (Formaldehyde, Acetaldehyde, Acrolein) by Test Product in the Exhaled-Breath Sessions | Difference in recorded weight of Sample 2, measured in grams, collected before and after product use in Exhaled Breath Sessions, Sample 2 was used to collect formaldehyde, acetaldehyde and acrolein, and was collected approximately 1 hour after Sample 1. | Posted | Mean | Standard Deviation | Grams | Samples collected during the approximately 1 hour controlled exhaled breath product use session on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme) |
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| Secondary | Summary Statistics of Total Cartridge Weight Change by Test Product, Per Subject, During the Ad Libitum-Use Sessions | Difference in recorded weight (measured in grams) by test product, per subject, collected before and after product use in ad libitum sessions | Posted | Mean | Standard Deviation | Grams | Samples were collected over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
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| Secondary | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Change in cartridge weight (measured in grams) as measured before and after a 12-hour ad-libitum use session of the product. | Cartridges of products utilized by participants during 12-hour ad-libitum-use session | Posted | Mean | Standard Deviation | Grams | Samples were collected over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) | Cartridges | Cartridges |
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| Secondary | Summary Statistics of Puff Count by Test Product During the Ad Libitum-Use Sessions | Number of puffs, by test product, per subject, taken during 12-hour ad libitum product use session | Posted | Mean | Standard Deviation | puffs | Data was collected over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
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| Secondary | Average Puff Duration by Test Product During the Ad Libitum-Use Sessions | Seconds per puff taken, by test product, per subject, during 12-hour ad libitum product use session | Posted | Mean | Standard Deviation | seconds per puff | Data was collected over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
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| Secondary | Total Puff Duration by Test Product During the Ad Libitum-Use Sessions | Total seconds puffing by test product, per subject, taken during 12-hour ad libitum product use session | Posted | Mean | Standard Deviation | Seconds | Data was collected over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
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| Secondary | Total Cartridges Used by Test Product During the Ad Libitum-Use Sessions | Total cartridges used by test product, per subject, taken during 12-hour ad libitum product use session | Posted | Mean | Standard Deviation | Cartridges | Data was collected over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
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| Secondary | Summary of Binary VAS-Derived Categorical "Use Product Again Questionnaire" Scores by Test Product | Visual Analog Scale (VAS) measuring self-reported response to "Use the product again" questionnaire was collected after each product use session. The questionnaire consists of a single question ("If given the opportunity, I would want to use this product again"). Participants indicated their willingness to use the product again by pointing to a line measuring 100mm, with scores measured from left to right and ranging between 0 to 100 mm. Scores closer to the right, and thus higher on the scale, indicated a greater willingness to utilize the product again. Raw scores were converted to a binary score as follows: VAS scores < 50 mm ≈ unwillingness to use the product again, and VAS scores ≥ 50 mm ≈ willingness to use product again. | Posted | Count of Participants | Participants | Data was collected at the end of the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
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| Secondary | Summary of Ordinal VAS-Derived Categorical "Use Product Again Questionnaire" Scores by Test Product | Visual Analog Scale (VAS) measuring self-reported response to willingness to use study product again. Questionnaire was collected after each product use session. Questionnaire consists of a single question ("If given the opportunity, I would want to use this product again") with VAS response range from "Definitely Would Not" to "Don't Care" to "Definitely Would". Participants indicated their willingness to use the product again by pointing to a line measuring 100mm, with scores measured from left to right and ranging between 0 to 100 mm. Scores closer to the right, and thus higher on the scale, indicated a greater willingness to utilize the product again. The raw scores were then converted to a binary, "unwilling" vs. "willing" to use response. Additionally, a 3-level ordinal response was computed using "unwilling" (VAS < 50 mm), "don't care" (VAS = 50 mm), and "willing" (VAS > 50 mm). | Posted | Count of Participants | Participants | Data was collected at the end of the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) |
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| Secondary | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Puff Count by Test Product (Pooled Over Cartridges) during 12-hour ad-libitum-use session of the product. | Cartridges of products utilized by participants during 12-hour ad-libitum-use session | Posted | Mean | Standard Deviation | Puffs | Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) | Cartridges | Cartridges |
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| Secondary | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Average puff duration (measured in seconds) by Test Product (Pooled Over Cartridges) during 12-hour ad-libitum-use session of the product. | Cartridges of products utilized by participants during 12-hour ad-libitum-use session | Posted | Mean | Standard Deviation | Seconds | Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) | Cartridges | Cartridges |
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| Secondary | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Total Puff Duration (measured in seconds) by Test Product (pooled over cartridges) during 12-hour ad-libitum-use session of the product. | Cartridges of products utilized by participants during 12-hour ad-libitum-use session | Posted | Mean | Standard Deviation | Seconds | Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) | Cartridges | Cartridges |
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| Secondary | Total Weight Change by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | Change in cartridge weight (measured in grams) as measured before and after a 12-hour ad-libitum use session of the product. | Cartridges of products utilized by participants during 12-hour ad-libitum-use session | Posted | Mean | Standard Deviation | Grams | Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) | Cartridges | Cartridges |
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| Secondary | Average Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | Average puff duration (measured in seconds) by Test Product, per completed cartridge, during a 12-hour ad-libitum use session of the product. | Cartridges of products utilized by participants during 12-hour ad-libitum-use session | Posted | Mean | Standard Deviation | Seconds | Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) | Cartridges | Cartridges |
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| Secondary | Puff Count by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | Puff count by Test Product, per completed cartridge, during a 12-hour ad-libitum use session of the product. | Cartridges of products utilized by participants during 12-hour ad-libitum-use session | Posted | Mean | Standard Deviation | Puffs | Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) | Cartridges | Cartridges |
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| Secondary | Total Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | Total Puff Duration (measured in seconds) by Test Product, per completed cartridge, during a 12-hour ad-libitum use session of the product. | Cartridges of products utilized by participants during 12-hour ad-libitum-use session | Posted | Mean | Standard Deviation | Seconds | Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) | Cartridges | Cartridges |
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|
| 0 |
| 32 |
| 0 |
| 32 |
| 3 |
| 32 |
| EG001 | e-Vapor Product B | Product XL40CB = Test EVP (formerly marketed by Nu Mark LLC as MarkTen® XL Bold Classic [4.0% NBW]) e-Vapor Product B: e-Vapor product | 0 | 32 | 0 | 32 | 1 | 32 |
| EG002 | e-Vapor Product C | Product XL35WM = Test EVP (formerly marketed by Nu Mark LLC as MarkTen® XL Winter Mint [3.5% NBW]) e-Vapor Product C: e-Vapor product | 0 | 32 | 0 | 32 | 3 | 32 |
| EG003 | e-Vapor Product D | Product XL40MB = Test EVP (formerly marketed by Nu Mark LLC as MarkTen® XL Bold Menthol [4.0% NBW]) e-Vapor Product D: e-Vapor product | 0 | 32 | 0 | 32 | 4 | 32 |
| EG004 | Day -1 Product Trial Non-randomized Subjects | Subjects who were not randomized after participating in the Day -1 Product Trial using all study products including: Product XL25F = Test e-vapor product (EVP) (formerly marketed by Nu Mark LLC as MarkTen® XL Fusion [2.5% nicotine by weight {NBW}]) e-Vapor Product A: e-Vapor product Product XL40CB = Test EVP (formerly marketed by Nu Mark LLC as MarkTen® XL Bold Classic [4.0% NBW]) e-Vapor Product B: e-Vapor product Product XL35WM = Test EVP (formerly marketed by Nu Mark LLC as MarkTen® XL Winter Mint [3.5% NBW] e-Vapor Product C: e-Vapor product Product XL40MB = Test EVP (formerly marketed by Nu Mark LLC as MarkTen® XL Bold Menthol [4.0% NBW]) e-Vapor Product D: e-Vapor product | 0 | 3 | 0 | 3 | 1 | 3 |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Oral Discomfort | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment | Coughing |
|
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| $20,000-$29,999 |
|
| $30,000-$39,999 |
|
| $40,000-$49,999 |
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| $50,000-$59,999 |
|
| $75,000-$99,999 |
|
| No answer |
|
| 12 years or GED |
|
| Some college |
|
| College graduate |
|
| Other |
|
| No answer |
|
| Self-Employed |
|
| Unemployed > 1 year |
|
| Unemployed < 1 year |
|
| Homemaker |
|
| Student |
|
| Retired |
|
| Unable to work |
|
| Discharged More Than 1 Year Ago |
|
| Never in military |
|
| No answer |
|
| Married/Partnered |
|
| Divorced/Separated/Widowed |
|
| No answer |
|
| No answer |
|
| No |
|
| No |
|
| Missing Response / Skip Logics |
|
| No |
|
| Missing Response / Skip Logics |
|
| Some Days |
|
| Not at all |
|
| Missing Response / Skip Logics |
|
| No |
|
| Missing Response / Skip Logics |
|
| No |
|
| Missing Response / Skip Logics |
|
| No |
|
| Missing Response / Skip Logics |
|
| No |
|
| Missing Response / Skip Logics |
|
| > 6 months |
|
| Missing Response / Skip Logics |
|
| No |
|
| Type 2 |
|
| Type 3 |
|
| Type 1 + Type 2 |
|
| Type 1 + Type 3 |
|
| Type 2 + Type 3 |
|
| Type 1 + Type 2 + Type 3 |
|
| Some Days |
|
| Not at all |
|
| No |
|
| No |
|
| Missing Response / Skip Logics |
|
| No |
|
| Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | ANCOVA | <.0001 | Mean Difference (Net) | 195.70 | 2-Sided | 95 | 122.01 | 269.38 | Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham). | Equivalence | Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. |
| Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | ANCOVA | <.0001 | Mean Difference (Net) | 168.83 | 2-Sided | 95 | 95.17 | 242.50 | Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham). | Equivalence | Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. |
| Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | ANCOVA | <.0001 | Mean Difference (Net) | 182.65 | 2-Sided | 95 | 108.63 | 256.67 | Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham). | Equivalence | Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. |
Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.
Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.
| Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | ANCOVA | <.0001 | Mean Difference (Net) | 6099.5 | 2-Sided | 95 | 4317.8 | 7881.2 | Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham). | Equivalence | Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. |
| Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | ANCOVA | <.0001 | Mean Difference (Net) | 6484.7 | 2-Sided | 95 | 4701.7 | 8267.6 | Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham). | Equivalence | Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. |
| Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | ANCOVA | <.0001 | Mean Difference (Net) | 5366.8 | 2-Sided | 95 | 3575.9 | 7157.7 | Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham). | Equivalence | Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. |
Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.
Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.
| Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | ANCOVA | 0.8217 | Mean Difference (Net) | 0.35 | 2-Sided | 95 | -2.70 | 3.40 | Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham). | Equivalence | Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. |
| Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | ANCOVA | <.0001 | Mean Difference (Net) | 21.11 | 2-Sided | 95 | 18.06 | 24.16 | Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | Equivalence | Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. |
| Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | ANCOVA | <.0001 | Mean Difference (Net) | 31.01 | 2-Sided | 95 | 27.91 | 34.12 | Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham). | Equivalence | Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. |
Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.
Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.
| Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | ANCOVA | .0310 | Mean Difference (Net) | 1199.7 | 2-Sided | 95 | 113.74 | 2285.7 | Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham). | Equivalence | Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. |
| Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | ANCOVA | <.0001 | Mean Difference (Net) | 3354.5 | 2-Sided | 95 | 2266.6 | 4442.3 | Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham). | Equivalence | Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. |
| Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | ANCOVA | <.0001 | Mean Difference (Net) | 2511.0 | 2-Sided | 95 | 1416.1 | 3605.9 | Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham). | Equivalence | Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. |
Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.
Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.
| Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | ANCOVA | 0.0003 | Mean Difference (Net) | 0.25 | 2-Sided | 95 | 0.12 | 0.38 | Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham). | Equivalence | Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. |
| Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | ANCOVA | <.0001 | Mean Difference (Net) | 0.34 | 2-Sided | 95 | 0.21 | 0.47 | Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham). | Equivalence | Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. |
| Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. | ANCOVA | <.0001 | Mean Difference (Net) | 0.30 | 2-Sided | 95 | 0.17 | 0.43 | Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham). | Equivalence | Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0. Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0. |
Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. |
| ANOVA |
| <.0001 |
| Mean Difference (Net) |
| 0.034 |
| 2-Sided |
| 95 |
| 0.030 |
| 0.038 |
| Equivalence |
Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. |
| Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. | ANOVA | <.0001 | Mean Difference (Net) | 0.040 | 2-Sided | 95 | 0.036 | 0.044 | Equivalence | Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. |
| Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. | ANOVA | <.0001 | Mean Difference (Net) | 0.037 | 2-Sided | 95 | 0.033 | 0.041 | Equivalence | Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. |
Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. |
| ANOVA |
| <.0001 |
| Mean Difference (Net) |
| 0.036 |
| 2-Sided |
| 95 |
| 0.032 |
| 0.041 |
| Equivalence |
Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. |
| Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. | ANOVA | <.0001 | Mean Difference (Net) | 0.041 | 2-Sided | 95 | 0.037 | 0.046 | Equivalence | Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. |
| Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. | ANOVA | <.0001 | Mean Difference (Net) | 0.038 | 2-Sided | 95 | 0.033 | 0.042 | Equivalence | Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. |
| Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. | ANCOVA | <.0001 | Mean Difference (Net) | 0.408 | 2-Sided | 95 | 0.280 | 0.537 | LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence. | Equivalence | Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. |
| Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. | ANCOVA | <.0001 | Mean Difference (Net) | 0.468 | 2-Sided | 95 | 0.339 | 0.596 | LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence. | Equivalence | Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. |
| Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. | ANCOVA | <.0001 | Mean Difference (Net) | 0.430 | 2-Sided | 95 | 0.301 | 0.559 | LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence. | Equivalence | Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0. |
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| Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0 | ANCOVA | <.0001 | Mean Difference (Final Values) | 241.32 | 2-Sided | 95 | 176.99 | 305.64 | LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence. | Equivalence | Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0 |
| Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0 | ANCOVA | <.0001 | Mean Difference (Final Values) | 248.22 | 2-Sided | 95 | 184.01 | 312.43 | LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence. | Equivalence | Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0 |
| Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0 | ANCOVA | <.0001 | Mean Difference (Final Values) | 257.92 | 2-Sided | 95 | 193.58 | 322.26 | LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence. | Equivalence | Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0 |
| Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0 | ANCOVA | <.0001 | Mean Difference (Final Values) | 2.203 | 2-Sided | 95 | 1.897 | 2.557 | LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence. | Equivalence | Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0 |
| Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0 | ANCOVA | <.0001 | Mean Difference (Final Values) | 2.101 | 2-Sided | 95 | 1.810 | 2.439 | LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence. | Equivalence | Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0 |
| Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0 | ANCOVA | <.0001 | Mean Difference (Final Values) | 2.052 | 2-Sided | 95 | 1.767 | 2.382 | LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence. | Equivalence | Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0 |
| Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0 | ANCOVA | <.0001 | Mean Difference (Final Values) | 568.35 | 2-Sided | 95 | 407.18 | 729.51 | LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence. | Equivalence | Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0 |
| Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0 | ANCOVA | <.0001 | Mean Difference (Final Values) | 562.00 | 2-Sided | 95 | 401.34 | 722.67 | LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence. | Equivalence | Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0 |
| Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0 | ANCOVA | <.0001 | Mean Difference (Final Values) | 517.23 | 2-Sided | 95 | 356.11 | 678.34 | LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence. | Equivalence | Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0 |
| Do not Want to Use |
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| Don't Care |
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| Do Not Want to Use |
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| Overall |
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| Overall |
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| Cartridges |
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