Tobacco Use
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERe-Vapor Product A
e-Vapor product XL25F
OTHERe-Vapor Product B
e-Vapor product XL40CB
OTHERe-Vapor Product C
e-Vapor product XL35WM
OTHERe-Vapor Product D
e-Vapor product XL40MB
Sponsors
Cato Research
Altria Client Services LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject candidates must satisfy the following criteria before being enrolled in the study: 1. provide voluntary consent to participate, as documented by the signed institutional review board (IRB)-approved informed consent form (ICF) for the study; 2. be between the ages of 21 and 65 years, inclusive, at the time of screening (Visit 1); 3. be positive for tobacco use by urine cotinine measurement (≥ 500 ng/mL) at Visit 1 (screening); 4. 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; 5. 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; 6. 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; 7. 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: * hormonal (e.g., oral, transdermal patch, implant, or injection) consistently for at least 3 months before Visit 1 (screening); * double barrier (i.e., condom with spermicide or diaphragm with spermicide) consistently for at least 30 days before Visit 1 (screening); * intrauterine device for at least 3 months before Visit 1 (screening); * Essure® or similar nonsurgical sterilization procedure at least 3 months before Visit 1 (screening); or * partner who has been vasectomized for at least 6 months (inclusive) before Visit 1 (screening); 8. 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; 9. not plan to quit e-vapor use in the next 30 days; 10. be willing to use all assigned EVPs during the study; and 11. 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. 1. have a history or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, diabetes, existing respiratory diseases (especially bronchospastic diseases and asthma), immunologic, psychiatric, cardiovascular disease, or any other condition(s) that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results (Note: Chronic medical conditions controlled and on stable medications \[over the past 3 months\] may not be exclusionary per investigator discretion); 2. have current evidence or any history of congestive heart failure; 3. have clinically significant abnormal findings on physical examination, vital signs, ECG, clinical laboratory results, or medical history, in the opinion of the investigator; 4. have systolic blood pressure \>140 mm Hg or diastolic blood pressure \>90 mm Hg at Visit 1 (screening) or at check-in for Visit 2; 5. have estimated creatinine clearance (by Cockcroft-Gault equation) \<80 mL/minute; 6. have liver enzymes (aspartate aminotransferase and alanine aminotransferase) ≥1.5 times the upper limit of normal at Visit 1 (screening); 7. have an acute illness (e.g., upper respiratory infection or viral infection) requiring treatment within 2 weeks before check-in at Visit 2; 8. have fever (\>100.5°F) at Visit 1 (screening) or at check-in for Visit 2; 9. have body mass index (BMI) greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Visit 1 (screening); 10. have positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Visit 1 (screening); 11. have used prescription or over-the-counter bronchodilator medication (e.g., inhaled or oral β-agonists) within 12 months of Visit 1 (screening) and Visit 2; 12. have diabetes mellitus that is not controlled by diet/exercise alone, in the opinion of the investigator; 13. have used prescription antidiabetic medication or insulin therapy within 12 months of Visit 1 (screening) and Visit 2; 14. have used medication for depression or asthma within 12 months of Visit 1 (screening) and Visit 2; 15. have a history of drug or alcohol abuse within 12 months of Visit 1 (screening) and Visit 2; 16. have had allergic or other known adverse reactions to menthol, propylene glycol, or glycerol; 17. if female, be pregnant, nursing, or planning to become pregnant during the study; 18. have participated in a clinical study for an investigational drug, medical device, biologic, or for a tobacco product within 30 days before Visit 1 (screening) and Visit 2; 19. be a current or former employee of the tobacco industry or a first-degree relative (e.g., parent, spouse, sibling, child) of a current or former employee of the tobacco industry or a named party or class representative in litigation with any tobacco company; 20. have been involved in the development of the study design/conduct or be a first-degree relative (e.g., parent, spouse, sibling, child) of someone involved in the development of the study design/conduct; 21. be a current employee or personnel involved with the study at the site; or 22. have participated in two or more ALCS studies within the past 12-month period before Visit 1 (screening) and check in at Visit 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Sham-Corrected Acrolein Summary Statistics by Test Product Group | 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) | 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. |
| Glycerin Residue Summary Statistics by Test-Product Group | 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) | 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. |
| Sham Glycerin Residue Summary Statistics by Test-Product Group | 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) | 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. |
| Total Sham-Corrected Glycerin Summary Statistics by Test Product Group | 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) | 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. |
| Menthol Residue Summary Statistics by Test-Product Group | 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) | 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. |
| Sham Menthol Residue Summary Statistics by Test-Product Group | 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) | 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. |
| Total Sham-Corrected Menthol Summary Statistics by Test Product Group | 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) | 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. |
| Propylene Glycol Residue Summary Statistics by Test-Product Group | 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) | 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. |
| Sham Propylene Glycol Residue Summary Statistics by Test-Product Group | 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) | 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. |
| Total Sham-Corrected Propylene Glycol Summary Statistics by Test Product Group | 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) | 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. |
| Formaldehyde Residue Summary Statistics by Test-Product Group | 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) | 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. |
| Sham Formaldehyde Residue Summary Statistics by Test-Product Group | 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) | 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. |
| Total Sham-Corrected Formaldehyde Summary Statistics by Test Product Group | 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) | 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. |
| Acetaldehyde Residue Summary Statistics by Test-Product Group | 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) | 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. |
| Sham Acetaldehyde Residue Summary Statistics by Test-Product Group | 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) | 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. |
| Total Sham-Corrected Acetaldehyde Summary Statistics by Test Product Group | 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) | 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. |
| Acrolein Residue Summary Statistics by Test-Product Group | 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) | 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. |
| Sham Acrolein Residue Summary Statistics by Test-Product Group | 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) | 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. |
| Nicotine Residue Summary Statistics by Test-Product Group | 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) | 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. |
| Sham Nicotine Residue Summary Statistics by Test-Product Group | 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) | 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. |
| Total Sham-Corrected Nicotine Summary Statistics by Test Product Group | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cartridge Weight (g) Change Summary Statistics for Sample 2 (Formaldehyde, Acetaldehyde, Acrolein) by Test Product in the Exhaled-Breath Sessions | 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) | 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. |
| Summary Statistics of Total Cartridge Weight Change by Test Product, Per Subject, During the Ad Libitum-Use 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) | Difference in recorded weight (measured in grams) by test product, per subject, collected before and after product use in ad libitum sessions |
| Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use 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) | Change in cartridge weight (measured in grams) as measured before and after a 12-hour ad-libitum use session of the product. |
| Summary Statistics of Puff Count by Test Product During the Ad Libitum-Use Sessions | 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) | Number of puffs, by test product, per subject, taken during 12-hour ad libitum product use session |
| Average Puff Duration by Test Product During the Ad Libitum-Use Sessions | 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) | Seconds per puff taken, by test product, per subject, during 12-hour ad libitum product use session |
| Total Puff Duration by Test Product During the Ad Libitum-Use Sessions | 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 seconds puffing by test product, per subject, taken during 12-hour ad libitum product use session |
| Total Cartridges Used by Test Product During the Ad Libitum-Use Sessions | 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, per subject, taken during 12-hour ad libitum product use session |
| Summary of Binary VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | 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) | 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. |
| Summary of Ordinal VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | 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) | 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). |
| Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | 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 (Pooled Over Cartridges) during 12-hour ad-libitum-use session of the product. |
| Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | 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 (measured in seconds) by Test Product (Pooled Over Cartridges) during 12-hour ad-libitum-use session of the product. |
| Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | 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 (measured in seconds) by Test Product (pooled over cartridges) during 12-hour ad-libitum-use session of the product. |
| Total Weight Change by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme) | Change in cartridge weight (measured in grams) as measured before and after a 12-hour ad-libitum use session of the product. |
| Average Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 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 (measured in seconds) by Test Product, per completed cartridge, during a 12-hour ad-libitum use session of the product. |
| Puff Count by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 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 a 12-hour ad-libitum use session of the product. |
| Total Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 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 (measured in seconds) by Test Product, per completed cartridge, during a 12-hour ad-libitum use session of the product. |
| Cartridge Weight (g) Change Summary Statistics for Sample 1 (Propylene Glycol, Glycerin, Nicotine, Menthol) by Test Product in the Exhaled-Breath Sessions | 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) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| BCAD 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 | 8 |
| 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 | 8 |
| 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 | 8 |
| Day-1 Trial Subjects who used at least one test product during the Visit 2, Day -1 product trial, but were not subsequently randomized | 3 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Alternates | 0 | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Total | ABDC | BCAD | CDBA | DACB | Day-1 Trial |
|---|---|---|---|---|---|---|
| 100 or more lifetime cigarettes Missing Response / Skip Logics | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| 100 or more lifetime cigarettes No | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| 100 or more lifetime cigarettes Yes | 32 Participants | 6 Participants | 7 Participants | 8 Participants | 8 Participants | 3 Participants |
| 30 Day Disposable E-Cigarette/Cartridge Count | 0.9 E-Cigarettes/Cartridges STANDARD_DEVIATION 1.85 | 0.6 E-Cigarettes/Cartridges STANDARD_DEVIATION 0.74 | 0.6 E-Cigarettes/Cartridges STANDARD_DEVIATION 0.74 | 0.3 E-Cigarettes/Cartridges STANDARD_DEVIATION 0.46 | 0.9 E-Cigarettes/Cartridges STANDARD_DEVIATION 1.64 | 3.7 E-Cigarettes/Cartridges STANDARD_DEVIATION 5.51 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 3 Participants |
| Age, Continuous | 36.7 Years STANDARD_DEVIATION 12.68 | 35.3 Years STANDARD_DEVIATION 12.02 | 34.9 Years STANDARD_DEVIATION 12.49 | 41.1 Years STANDARD_DEVIATION 15.95 | 35.4 Years STANDARD_DEVIATION 11.73 | 37.7 Years STANDARD_DEVIATION 14.22 |
| Annual Household Income <$20,000 | 18 Participants | 4 Participants | 3 Participants | 3 Participants | 7 Participants | 1 Participants |
| Annual Household Income $20,000-$29,999 | 8 Participants | 0 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants |
| Annual Household Income $30,000-$39,999 | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Annual Household Income $40,000-$49,999 | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Annual Household Income $50,000-$59,999 | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Annual Household Income $75,000-$99,999 | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Annual Household Income No answer | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Body Mass Index (BMI) | 27.69 kg/m² STANDARD_DEVIATION 5.254 | 28.16 kg/m² STANDARD_DEVIATION 5.535 | 29.89 kg/m² STANDARD_DEVIATION 6.014 | 28.48 kg/m² STANDARD_DEVIATION 3.699 | 25.26 kg/m² STANDARD_DEVIATION 5.177 | 24.97 kg/m² STANDARD_DEVIATION 6.035 |
| Current Quit Smoking Duration < 6 months | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Current Quit Smoking Duration > 6 months | 9 Participants | 1 Participants | 2 Participants | 3 Participants | 3 Participants | 0 Participants |
| Current Quit Smoking Duration Missing Response / Skip Logics | 25 Participants | 7 Participants | 6 Participants | 5 Participants | 4 Participants | 3 Participants |
| Daily Cigarette Use | 8.6 number of cigarettes STANDARD_DEVIATION 5.64 | 9.7 number of cigarettes STANDARD_DEVIATION 5.96 | 9.0 number of cigarettes STANDARD_DEVIATION 4.3 | 9.6 number of cigarettes STANDARD_DEVIATION 5.55 | 2.8 number of cigarettes STANDARD_DEVIATION 2.22 | 14.0 number of cigarettes STANDARD_DEVIATION 8.49 |
| Daily Smoking Missing Response / Skip Logics | 13 Participants | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 1 Participants |
| Daily Smoking No | 6 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants |
| Daily Smoking Yes | 16 Participants | 4 Participants | 4 Participants | 5 Participants | 2 Participants | 1 Participants |
| e-Cigarette Length of Use | 17.5 months STANDARD_DEVIATION 10.9 | 17.8 months STANDARD_DEVIATION 10.98 | 14.5 months STANDARD_DEVIATION 6.02 | 22.5 months STANDARD_DEVIATION 15.96 | 17.8 months STANDARD_DEVIATION 8.7 | 11.3 months STANDARD_DEVIATION 11.02 |
| e-Cigarette Use Frequency in Past 30 Days Every Day | 28 Participants | 4 Participants | 8 Participants | 6 Participants | 7 Participants | 3 Participants |
| e-Cigarette Use Frequency in Past 30 Days Not at all | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| e-Cigarette Use Frequency in Past 30 Days Some Days | 7 Participants | 4 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants |
| Education 12 years or GED | 13 Participants | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 1 Participants |
| Education 9-11 years | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Education College graduate | 4 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Education No answer | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Education Other | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Education Some college | 14 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants | 1 Participants |
| Employment Status Homemaker | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Employment Status Retired | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Employment Status Self-Employed | 5 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Employment Status Student | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants |
| Employment Status Unable to work | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Employment Status Unemployed < 1 year | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Employment Status Unemployed > 1 year | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Employment Status Wage Earner | 16 Participants | 2 Participants | 6 Participants | 3 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 5 Participants | 7 Participants | 8 Participants | 8 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 172.1 cm STANDARD_DEVIATION 10.04 | 168.6 cm STANDARD_DEVIATION 8.16 | 174.6 cm STANDARD_DEVIATION 7.99 | 170.7 cm STANDARD_DEVIATION 10.28 | 172.7 cm STANDARD_DEVIATION 8.4 | 177.7 cm STANDARD_DEVIATION 22.64 |
| Length of Consistent Smoking | 13.8 Years STANDARD_DEVIATION 11.57 | 9.9 Years STANDARD_DEVIATION 8.23 | 12.7 Years STANDARD_DEVIATION 9.69 | 19.1 Years STANDARD_DEVIATION 14.7 | 13.0 Years STANDARD_DEVIATION 13.9 | 13.7 Years STANDARD_DEVIATION 7.09 |
| Marital Status Divorced/Separated/Widowed | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants |
| Marital Status Married/Partnered | 5 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Marital Status No answer | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Single | 23 Participants | 5 Participants | 4 Participants | 6 Participants | 6 Participants | 2 Participants |
| Menthol Cigarettes Regularly Missing Response / Skip Logics | 13 Participants | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 1 Participants |
| Menthol Cigarettes Regularly No | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Menthol Cigarettes Regularly Yes | 19 Participants | 6 Participants | 4 Participants | 4 Participants | 3 Participants | 2 Participants |
| Military Experience Active Duty | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Military Experience Discharged More Than 1 Year Ago | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Military Experience Never in military | 31 Participants | 6 Participants | 7 Participants | 8 Participants | 7 Participants | 3 Participants |
| Military Experience No answer | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Milliliters of E-Liquid/day in last 30 Days | 3.3 ml/day STANDARD_DEVIATION 4.94 | 3.6 ml/day STANDARD_DEVIATION 6.72 | 2.1 ml/day STANDARD_DEVIATION 3.31 | 4.6 ml/day STANDARD_DEVIATION 6.7 | 3.5 ml/day STANDARD_DEVIATION 3.12 | 2.0 ml/day STANDARD_DEVIATION 3.46 |
| Number of Days of e-cigarette Use in Past Week | 6.5 days STANDARD_DEVIATION 0.89 | 6.0 days STANDARD_DEVIATION 1.2 | 6.6 days STANDARD_DEVIATION 0.74 | 6.6 days STANDARD_DEVIATION 1.06 | 6.8 days STANDARD_DEVIATION 0.46 | 7.0 days STANDARD_DEVIATION 0 |
| Plan to Quit E-Cigarettes No | 35 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 3 Participants |
| Plan to Quit E-Cigarettes Yes | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Plan to Quit Smoking Missing Response / Skip Logics | 11 Participants | 2 Participants | 3 Participants | 2 Participants | 4 Participants | 0 Participants |
| Plan to Quit Smoking No | 20 Participants | 5 Participants | 5 Participants | 5 Participants | 2 Participants | 3 Participants |
| Plan to Quit Smoking Yes | 4 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants |
| Previous Cigarette Usage No | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Previous Cigarette Usage Yes | 34 Participants | 7 Participants | 8 Participants | 8 Participants | 8 Participants | 3 Participants |
| Previous E-Cigarette Usage No | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Previous E-Cigarette Usage Yes | 35 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 3 Participants |
| Previously Quit Smoking Missing Response / Skip Logics | 13 Participants | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 1 Participants |
| Previously Quit Smoking No | 15 Participants | 4 Participants | 3 Participants | 4 Participants | 3 Participants | 1 Participants |
| Previously Quit Smoking Yes | 7 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants |
| Quit E-Cigarettes in Last Year No | 34 Participants | 7 Participants | 8 Participants | 8 Participants | 8 Participants | 3 Participants |
| Quit E-Cigarettes in Last Year Yes | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Quit Smoking Completely Missing Response / Skip Logics | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Quit Smoking Completely No | 23 Participants | 6 Participants | 5 Participants | 5 Participants | 4 Participants | 3 Participants |
| Quit Smoking Completely Yes | 10 Participants | 1 Participants | 2 Participants | 3 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 6 Participants | 7 Participants | 5 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 1 Participants | 1 Participants | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Female | 15 Participants | 4 Participants | 4 Participants | 3 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 20 Participants | 4 Participants | 4 Participants | 5 Participants | 5 Participants | 2 Participants |
| Sexual Identity Heterosexual or Straight | 33 Participants | 7 Participants | 7 Participants | 8 Participants | 8 Participants | 3 Participants |
| Sexual Identity No answer | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Smoke on a regular basis Missing Response / Skip Logics | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Smoke on a regular basis No | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Smoke on a regular basis Yes | 33 Participants | 7 Participants | 7 Participants | 8 Participants | 8 Participants | 3 Participants |
| Smoking Frequency in past 30 days Every Day | 13 Participants | 4 Participants | 4 Participants | 3 Participants | 1 Participants | 1 Participants |
| Smoking Frequency in past 30 days Missing Response / Skip Logics | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Smoking Frequency in past 30 days Not at all | 11 Participants | 1 Participants | 2 Participants | 3 Participants | 4 Participants | 1 Participants |
| Smoking Frequency in past 30 days Some Days | 9 Participants | 2 Participants | 1 Participants | 2 Participants | 3 Participants | 1 Participants |
| Type of e-Cigarette and e-Vapor Product Use Type 1 | 4 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Type of e-Cigarette and e-Vapor Product Use Type 1 + Type 2 | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Type of e-Cigarette and e-Vapor Product Use Type 1 + Type 2 + Type 3 | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Type of e-Cigarette and e-Vapor Product Use Type 1 + Type 3 | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Type of e-Cigarette and e-Vapor Product Use Type 2 | 8 Participants | 1 Participants | 4 Participants | 2 Participants | 0 Participants | 1 Participants |
| Type of e-Cigarette and e-Vapor Product Use Type 2 + Type 3 | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Type of e-Cigarette and e-Vapor Product Use Type 3 | 17 Participants | 4 Participants | 2 Participants | 5 Participants | 6 Participants | 0 Participants |
| Weight | 82.1 kg STANDARD_DEVIATION 17.56 | 80.4 kg STANDARD_DEVIATION 17.9 | 91.3 kg STANDARD_DEVIATION 21.44 | 82.8 kg STANDARD_DEVIATION 11.91 | 76.0 kg STANDARD_DEVIATION 19.6 | 77.1 kg STANDARD_DEVIATION 11.46 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 | 0 / 32 | 0 / 32 | 0 / 3 |
| other Total, other adverse events | 3 / 32 | 1 / 32 | 3 / 32 | 4 / 32 | 1 / 3 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 | 0 / 32 | 0 / 32 | 0 / 3 |
Outcome results
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Acetaldehyde Residue Summary Statistics by Test-Product Group | 0.50 Micrograms | Standard Deviation 0 |
| e-Vapor Product B | Acetaldehyde Residue Summary Statistics by Test-Product Group | 0.50 Micrograms | Standard Deviation 0 |
| e-Vapor Product C | Acetaldehyde Residue Summary Statistics by Test-Product Group | 0.50 Micrograms | Standard Deviation 0 |
| e-Vapor Product D | Acetaldehyde Residue Summary Statistics by Test-Product Group | 0.50 Micrograms | Standard Deviation 0 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Acrolein Residue Summary Statistics by Test-Product Group | 0.63 Micrograms | Standard Error 0 |
| e-Vapor Product B | Acrolein Residue Summary Statistics by Test-Product Group | 0.63 Micrograms | Standard Error 0 |
| e-Vapor Product C | Acrolein Residue Summary Statistics by Test-Product Group | 0.63 Micrograms | Standard Error 0 |
| e-Vapor Product D | Acrolein Residue Summary Statistics by Test-Product Group | 0.63 Micrograms | Standard Error 0 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Formaldehyde Residue Summary Statistics by Test-Product Group | 1.0 Micrograms | Standard Deviation 0.74 |
| e-Vapor Product B | Formaldehyde Residue Summary Statistics by Test-Product Group | 1.1 Micrograms | Standard Deviation 0.95 |
| e-Vapor Product C | Formaldehyde Residue Summary Statistics by Test-Product Group | 1.3 Micrograms | Standard Deviation 0.92 |
| e-Vapor Product D | Formaldehyde Residue Summary Statistics by Test-Product Group | 1.2 Micrograms | Standard Deviation 0.85 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Glycerin Residue Summary Statistics by Test-Product Group | 5964.4 Micrograms | Standard Deviation 5029.33 |
| e-Vapor Product B | Glycerin Residue Summary Statistics by Test-Product Group | 5707.3 Micrograms | Standard Deviation 5015.41 |
| e-Vapor Product C | Glycerin Residue Summary Statistics by Test-Product Group | 6516.6 Micrograms | Standard Deviation 5387.8 |
| e-Vapor Product D | Glycerin Residue Summary Statistics by Test-Product Group | 5682.4 Micrograms | Standard Deviation 5156.04 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Menthol Residue Summary Statistics by Test-Product Group | 0.4 Micrograms | Standard Deviation 0.13 |
| e-Vapor Product B | Menthol Residue Summary Statistics by Test-Product Group | 0.4 Micrograms | Standard Deviation 0.08 |
| e-Vapor Product C | Menthol Residue Summary Statistics by Test-Product Group | 22.1 Micrograms | Standard Deviation 9.99 |
| e-Vapor Product D | Menthol Residue Summary Statistics by Test-Product Group | 31.3 Micrograms | Standard Deviation 15.12 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Nicotine Residue Summary Statistics by Test-Product Group | 87.1 Micrograms | Standard Deviation 120.11 |
| e-Vapor Product B | Nicotine Residue Summary Statistics by Test-Product Group | 192.3 Micrograms | Standard Deviation 268.53 |
| e-Vapor Product C | Nicotine Residue Summary Statistics by Test-Product Group | 174.1 Micrograms | Standard Deviation 208.64 |
| e-Vapor Product D | Nicotine Residue Summary Statistics by Test-Product Group | 182.8 Micrograms | Standard Deviation 253.88 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Propylene Glycol Residue Summary Statistics by Test-Product Group | 1697.6 Micrograms | Standard Deviation 2351.62 |
| e-Vapor Product B | Propylene Glycol Residue Summary Statistics by Test-Product Group | 1047.7 Micrograms | Standard Deviation 1497.14 |
| e-Vapor Product C | Propylene Glycol Residue Summary Statistics by Test-Product Group | 3343.4 Micrograms | Standard Deviation 4090.27 |
| e-Vapor Product D | Propylene Glycol Residue Summary Statistics by Test-Product Group | 2675.8 Micrograms | Standard Deviation 3794.98 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Sham Acetaldehyde Residue Summary Statistics by Test-Product Group | 0.50 Micrograms | Standard Deviation 0 |
| e-Vapor Product B | Sham Acetaldehyde Residue Summary Statistics by Test-Product Group | 0.50 Micrograms | Standard Deviation 0 |
| e-Vapor Product C | Sham Acetaldehyde Residue Summary Statistics by Test-Product Group | 0.50 Micrograms | Standard Deviation 0 |
| e-Vapor Product D | Sham Acetaldehyde Residue Summary Statistics by Test-Product Group | 0.50 Micrograms | Standard Deviation 0 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Sham Acrolein Residue Summary Statistics by Test-Product Group | 0.6 Micrograms | Standard Error 0 |
| e-Vapor Product B | Sham Acrolein Residue Summary Statistics by Test-Product Group | 0.6 Micrograms | Standard Error 0 |
| e-Vapor Product C | Sham Acrolein Residue Summary Statistics by Test-Product Group | 0.6 Micrograms | Standard Error 0 |
| e-Vapor Product D | Sham Acrolein Residue Summary Statistics by Test-Product Group | 0.6 Micrograms | Standard Error 0 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Sham Formaldehyde Residue Summary Statistics by Test-Product Group | 0.8 Micrograms | Standard Deviation 0.66 |
| e-Vapor Product B | Sham Formaldehyde Residue Summary Statistics by Test-Product Group | 0.8 Micrograms | Standard Deviation 0.63 |
| e-Vapor Product C | Sham Formaldehyde Residue Summary Statistics by Test-Product Group | 1.0 Micrograms | Standard Deviation 0.79 |
| e-Vapor Product D | Sham Formaldehyde Residue Summary Statistics by Test-Product Group | 1.0 Micrograms | Standard Deviation 0.79 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Sham Glycerin Residue Summary Statistics by Test-Product Group | 15.4 Micrograms | Standard Deviation 16.49 |
| e-Vapor Product B | Sham Glycerin Residue Summary Statistics by Test-Product Group | 11.1 Micrograms | Standard Deviation 5.01 |
| e-Vapor Product C | Sham Glycerin Residue Summary Statistics by Test-Product Group | 15.4 Micrograms | Standard Deviation 16.53 |
| e-Vapor Product D | Sham Glycerin Residue Summary Statistics by Test-Product Group | 10.9 Micrograms | Standard Deviation 2.65 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Sham Menthol Residue Summary Statistics by Test-Product Group | 0.5 Micrograms | Standard Deviation 0.42 |
| e-Vapor Product B | Sham Menthol Residue Summary Statistics by Test-Product Group | 0.4 Micrograms | Standard Deviation 0.08 |
| e-Vapor Product C | Sham Menthol Residue Summary Statistics by Test-Product Group | 0.4 Micrograms | Standard Deviation 0.08 |
| e-Vapor Product D | Sham Menthol Residue Summary Statistics by Test-Product Group | 0.4 Micrograms | Standard Deviation 0.08 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Sham Nicotine Residue Summary Statistics by Test-Product Group | 0.9 Micrograms | Standard Deviation 0.66 |
| e-Vapor Product B | Sham Nicotine Residue Summary Statistics by Test-Product Group | 0.9 Micrograms | Standard Deviation 0.66 |
| e-Vapor Product C | Sham Nicotine Residue Summary Statistics by Test-Product Group | 0.9 Micrograms | Standard Deviation 0.7 |
| e-Vapor Product D | Sham Nicotine Residue Summary Statistics by Test-Product Group | 0.9 Micrograms | Standard Deviation 0.69 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Sham Propylene Glycol Residue Summary Statistics by Test-Product Group | 14.9 Micrograms | Standard Deviation 1.54 |
| e-Vapor Product B | Sham Propylene Glycol Residue Summary Statistics by Test-Product Group | 14.9 Micrograms | Standard Deviation 2.18 |
| e-Vapor Product C | Sham Propylene Glycol Residue Summary Statistics by Test-Product Group | 15.4 Micrograms | Standard Deviation 2.97 |
| e-Vapor Product D | Sham Propylene Glycol Residue Summary Statistics by Test-Product Group | 14.6 Micrograms | Standard Deviation 0.66 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Total Sham-Corrected Acetaldehyde Summary Statistics by Test Product Group | 0.0 Micrograms | Standard Deviation 0 |
| e-Vapor Product B | Total Sham-Corrected Acetaldehyde Summary Statistics by Test Product Group | 0.0 Micrograms | Standard Deviation 0 |
| e-Vapor Product C | Total Sham-Corrected Acetaldehyde Summary Statistics by Test Product Group | 0.0 Micrograms | Standard Deviation 0 |
| e-Vapor Product D | Total Sham-Corrected Acetaldehyde Summary Statistics by Test Product Group | 0.0 Micrograms | Standard Deviation 0 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Total Sham-Corrected Acrolein Summary Statistics by Test Product Group | 0.0 Micrograms | Standard Error 0 |
| e-Vapor Product B | Total Sham-Corrected Acrolein Summary Statistics by Test Product Group | 0.0 Micrograms | Standard Error 0 |
| e-Vapor Product C | Total Sham-Corrected Acrolein Summary Statistics by Test Product Group | 0.0 Micrograms | Standard Error 0 |
| e-Vapor Product D | Total Sham-Corrected Acrolein Summary Statistics by Test Product Group | 0.0 Micrograms | Standard Error 0 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Total Sham-Corrected Formaldehyde Summary Statistics by Test Product Group | 0.19 Micrograms | Standard Deviation 0.241 |
| e-Vapor Product B | Total Sham-Corrected Formaldehyde Summary Statistics by Test Product Group | 0.33 Micrograms | Standard Deviation 0.65 |
| e-Vapor Product C | Total Sham-Corrected Formaldehyde Summary Statistics by Test Product Group | 0.35 Micrograms | Standard Deviation 0.326 |
| e-Vapor Product D | Total Sham-Corrected Formaldehyde Summary Statistics by Test Product Group | 0.27 Micrograms | Standard Deviation 0.329 |
Comparison: 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.p-value: 0.000295% CI: [0.12, 0.38]ANCOVA
Comparison: 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.p-value: 0.000395% CI: [0.12, 0.38]ANCOVA
Comparison: 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.p-value: <0.000195% CI: [0.21, 0.47]ANCOVA
Comparison: 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.p-value: <0.000195% CI: [0.17, 0.43]ANCOVA
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Total Sham-Corrected Glycerin Summary Statistics by Test Product Group | 5949.0 Micrograms | Standard Deviation 5033.63 |
| e-Vapor Product B | Total Sham-Corrected Glycerin Summary Statistics by Test Product Group | 5696.2 Micrograms | Standard Deviation 5015.99 |
| e-Vapor Product C | Total Sham-Corrected Glycerin Summary Statistics by Test Product Group | 6501.2 Micrograms | Standard Deviation 5385.54 |
| e-Vapor Product D | Total Sham-Corrected Glycerin Summary Statistics by Test Product Group | 5671.5 Micrograms | Standard Deviation 5155.84 |
Comparison: 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.p-value: <0.000195% CI: [4191.1, 7753.6]ANCOVA
Comparison: 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.p-value: <0.000195% CI: [4317.8, 7881.2]ANCOVA
Comparison: 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.p-value: <0.000195% CI: [4701.7, 8267.6]ANCOVA
Comparison: 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.p-value: <0.000195% CI: [3575.9, 7157.7]ANCOVA
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Total Sham-Corrected Menthol Summary Statistics by Test Product Group | -0.1 Micrograms | Standard Deviation 0.3 |
| e-Vapor Product B | Total Sham-Corrected Menthol Summary Statistics by Test Product Group | 0.0 Micrograms | Standard Deviation 0 |
| e-Vapor Product C | Total Sham-Corrected Menthol Summary Statistics by Test Product Group | 21.7 Micrograms | Standard Deviation 9.98 |
| e-Vapor Product D | Total Sham-Corrected Menthol Summary Statistics by Test Product Group | 30.9 Micrograms | Standard Deviation 15.12 |
Comparison: 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.p-value: 0.91595% CI: [-2.92, 3.25]ANCOVA
Comparison: 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.p-value: 0.821795% CI: [-2.7, 3.4]ANCOVA
Comparison: 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.p-value: <0.000195% CI: [18.06, 24.16]ANCOVA
Comparison: 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.p-value: <0.000195% CI: [27.91, 34.12]ANCOVA
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Total Sham-Corrected Nicotine Summary Statistics by Test Product Group | 86.1 Micrograms | Standard Deviation 120.4 |
| e-Vapor Product B | Total Sham-Corrected Nicotine Summary Statistics by Test Product Group | 191.4 Micrograms | Standard Deviation 268.78 |
| e-Vapor Product C | Total Sham-Corrected Nicotine Summary Statistics by Test Product Group | 173.1 Micrograms | Standard Deviation 208.93 |
| e-Vapor Product D | Total Sham-Corrected Nicotine Summary Statistics by Test Product Group | 181.8 Micrograms | Standard Deviation 254.23 |
Comparison: 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.p-value: 0.018495% CI: [15.77, 163.11]ANCOVA
Comparison: 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.p-value: <0.000195% CI: [122.01, 269.38]ANCOVA
Comparison: 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.p-value: <0.000195% CI: [95.17, 242.5]ANCOVA
Comparison: 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.p-value: <0.000195% CI: [108.63, 256.67]ANCOVA
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Total Sham-Corrected Propylene Glycol Summary Statistics by Test Product Group | 1682.7 Micrograms | Standard Deviation 2351.82 |
| e-Vapor Product B | Total Sham-Corrected Propylene Glycol Summary Statistics by Test Product Group | 1032.8 Micrograms | Standard Deviation 1497.42 |
| e-Vapor Product C | Total Sham-Corrected Propylene Glycol Summary Statistics by Test Product Group | 3328.0 Micrograms | Standard Deviation 4090.9 |
| e-Vapor Product D | Total Sham-Corrected Propylene Glycol Summary Statistics by Test Product Group | 2661.2 Micrograms | Standard Deviation 3795.07 |
Comparison: 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.p-value: 0.003195% CI: [592.14, 2764.6]ANCOVA
Comparison: 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.p-value: 0.03195% CI: [113.74, 2285.7]ANCOVA
Comparison: 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.p-value: <0.000195% CI: [2266.6, 4442.3]ANCOVA
Comparison: 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.p-value: <0.000195% CI: [1416.1, 3605.9]ANCOVA
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.
Time frame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Population: Cartridges of products utilized by participants during 12-hour ad-libitum-use session
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| e-Vapor Product A | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 2.674 Seconds | Standard Deviation 1.13172 |
| e-Vapor Product A | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 2.487 Seconds | Standard Deviation 1.05031 |
| e-Vapor Product A | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 3 | 4.761 Seconds | Standard Deviation 0.06038 |
| e-Vapor Product A | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 2.634 Seconds | Standard Deviation 1.13792 |
| e-Vapor Product B | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 2.506 Seconds | Standard Deviation 1.17333 |
| e-Vapor Product B | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 2.369 Seconds | Standard Deviation 1.10274 |
| e-Vapor Product B | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 3.111 Seconds | Standard Deviation 1.52758 |
| e-Vapor Product B | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 3 | 3.598 Seconds | Standard Deviation 0 |
| e-Vapor Product C | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 3.004 Seconds | Standard Deviation 0.89069 |
| e-Vapor Product C | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 2.402 Seconds | Standard Deviation 0.94449 |
| e-Vapor Product C | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 3 | 3.330 Seconds | Standard Deviation 0 |
| e-Vapor Product C | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 2.275 Seconds | Standard Deviation 0.92685 |
| e-Vapor Product D | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 2.252 Seconds | Standard Deviation 0.81028 |
| e-Vapor Product D | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 2.194 Seconds | Standard Deviation 0.73162 |
| e-Vapor Product D | Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 2.685 Seconds | Standard Deviation 1.32845 |
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
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Average Puff Duration by Test Product During the Ad Libitum-Use Sessions | 2.471 seconds per puff | Standard Deviation 1.01786 |
| e-Vapor Product B | Average Puff Duration by Test Product During the Ad Libitum-Use Sessions | 2.373 seconds per puff | Standard Deviation 1.10711 |
| e-Vapor Product C | Average Puff Duration by Test Product During the Ad Libitum-Use Sessions | 2.249 seconds per puff | Standard Deviation 0.89143 |
| e-Vapor Product D | Average Puff Duration by Test Product During the Ad Libitum-Use Sessions | 2.209 seconds per puff | Standard Deviation 0.75672 |
Comparison: Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0p-value: <0.000195% CI: [1.915, 2.58]ANCOVA
Comparison: Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0p-value: <0.000195% CI: [1.897, 2.557]ANCOVA
Comparison: Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0p-value: <0.000195% CI: [1.81, 2.439]ANCOVA
Comparison: Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0p-value: <0.000195% CI: [1.767, 2.382]ANCOVA
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.
Time frame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Population: Cartridges of products utilized by participants during 12-hour ad-libitum-use session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Average Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 3.033 Seconds | Standard Deviation 1.30359 |
| e-Vapor Product B | Average Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 3.004 Seconds | Standard Deviation 1.27635 |
| e-Vapor Product C | Average Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 3.019 Seconds | Standard Deviation 0.93719 |
| e-Vapor Product D | Average Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 2.491 Seconds | Standard Deviation 0.60612 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Cartridge Weight (g) Change Summary Statistics for Sample 1 (Propylene Glycol, Glycerin, Nicotine, Menthol) by Test Product in the Exhaled-Breath Sessions | 0.0352 Grams | Standard Deviation 0.008701 |
| e-Vapor Product B | Cartridge Weight (g) Change Summary Statistics for Sample 1 (Propylene Glycol, Glycerin, Nicotine, Menthol) by Test Product in the Exhaled-Breath Sessions | 0.0337 Grams | Standard Deviation 0.011374 |
| e-Vapor Product C | Cartridge Weight (g) Change Summary Statistics for Sample 1 (Propylene Glycol, Glycerin, Nicotine, Menthol) by Test Product in the Exhaled-Breath Sessions | 0.0402 Grams | Standard Deviation 0.012596 |
| e-Vapor Product D | Cartridge Weight (g) Change Summary Statistics for Sample 1 (Propylene Glycol, Glycerin, Nicotine, Menthol) by Test Product in the Exhaled-Breath Sessions | 0.0367 Grams | Standard Deviation 0.012324 |
Comparison: Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.p-value: <0.000195% CI: [0.031, 0.039]ANOVA
Comparison: Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.p-value: <0.000195% CI: [0.03, 0.038]ANOVA
Comparison: Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.p-value: <0.000195% CI: [0.036, 0.044]ANOVA
Comparison: Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.p-value: <0.000195% CI: [0.033, 0.041]ANOVA
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Cartridge Weight (g) Change Summary Statistics for Sample 2 (Formaldehyde, Acetaldehyde, Acrolein) by Test Product in the Exhaled-Breath Sessions | 0.0356 Grams | Standard Deviation 0.01153 |
| e-Vapor Product B | Cartridge Weight (g) Change Summary Statistics for Sample 2 (Formaldehyde, Acetaldehyde, Acrolein) by Test Product in the Exhaled-Breath Sessions | 0.0363 Grams | Standard Deviation 0.011936 |
| e-Vapor Product C | Cartridge Weight (g) Change Summary Statistics for Sample 2 (Formaldehyde, Acetaldehyde, Acrolein) by Test Product in the Exhaled-Breath Sessions | 0.0412 Grams | Standard Deviation 0.014581 |
| e-Vapor Product D | Cartridge Weight (g) Change Summary Statistics for Sample 2 (Formaldehyde, Acetaldehyde, Acrolein) by Test Product in the Exhaled-Breath Sessions | 0.0379 Grams | Standard Deviation 0.012395 |
Comparison: Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.p-value: <0.000195% CI: [0.031, 0.04]ANOVA
Comparison: Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.p-value: <0.000195% CI: [0.032, 0.041]ANOVA
Comparison: Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.p-value: <0.000195% CI: [0.037, 0.046]ANOVA
Comparison: Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.p-value: <0.000195% CI: [0.033, 0.042]ANOVA
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.
Time frame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Population: Cartridges of products utilized by participants during 12-hour ad-libitum-use session
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| e-Vapor Product A | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 3 | 66.500 Puffs | Standard Deviation 27.57716 |
| e-Vapor Product A | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 164.250 Puffs | Standard Deviation 121.568 |
| e-Vapor Product A | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 247.156 Puffs | Standard Deviation 146.7016 |
| e-Vapor Product A | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 222.762 Puffs | Standard Deviation 145.3878 |
| e-Vapor Product B | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 197.065 Puffs | Standard Deviation 147.5464 |
| e-Vapor Product B | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 3 | 322.000 Puffs | Standard Deviation 0 |
| e-Vapor Product B | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 200.243 Puffs | Standard Deviation 140.1773 |
| e-Vapor Product B | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 195.600 Puffs | Standard Deviation 98.79929 |
| e-Vapor Product C | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 202.154 Puffs | Standard Deviation 143.077 |
| e-Vapor Product C | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 217.969 Puffs | Standard Deviation 143.7912 |
| e-Vapor Product C | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 117.333 Puffs | Standard Deviation 130.9712 |
| e-Vapor Product C | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 3 | 205.000 Puffs | Standard Deviation 0 |
| e-Vapor Product D | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 176.750 Puffs | Standard Deviation 193.319 |
| e-Vapor Product D | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 220.032 Puffs | Standard Deviation 141.3675 |
| e-Vapor Product D | Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 215.086 Puffs | Standard Deviation 145.3491 |
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.
Time frame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Population: Cartridges of products utilized by participants during 12-hour ad-libitum-use session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Puff Count by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 298.300 Puffs | Standard Deviation 155.1444 |
| e-Vapor Product B | Puff Count by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 159.714 Puffs | Standard Deviation 108.9567 |
| e-Vapor Product C | Puff Count by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 280.000 Puffs | Standard Deviation 137.6311 |
| e-Vapor Product D | Puff Count by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 311.400 Puffs | Standard Deviation 171.0111 |
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.
Time frame: 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)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| e-Vapor Product A | Summary of Binary VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Want to Use | 29 Participants |
| e-Vapor Product A | Summary of Binary VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Do not Want to Use | 3 Participants |
| e-Vapor Product B | Summary of Binary VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Do not Want to Use | 3 Participants |
| e-Vapor Product B | Summary of Binary VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Want to Use | 29 Participants |
| e-Vapor Product C | Summary of Binary VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Want to Use | 27 Participants |
| e-Vapor Product C | Summary of Binary VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Do not Want to Use | 5 Participants |
| e-Vapor Product D | Summary of Binary VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Want to Use | 28 Participants |
| e-Vapor Product D | Summary of Binary VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Do not Want to Use | 4 Participants |
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).
Time frame: 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)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| e-Vapor Product A | Summary of Ordinal VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Want to Use | 29 Participants |
| e-Vapor Product A | Summary of Ordinal VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Do Not Want to Use | 3 Participants |
| e-Vapor Product A | Summary of Ordinal VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Don't Care | 0 Participants |
| e-Vapor Product B | Summary of Ordinal VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Want to Use | 29 Participants |
| e-Vapor Product B | Summary of Ordinal VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Do Not Want to Use | 3 Participants |
| e-Vapor Product B | Summary of Ordinal VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Don't Care | 0 Participants |
| e-Vapor Product C | Summary of Ordinal VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Don't Care | 1 Participants |
| e-Vapor Product C | Summary of Ordinal VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Want to Use | 26 Participants |
| e-Vapor Product C | Summary of Ordinal VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Do Not Want to Use | 5 Participants |
| e-Vapor Product D | Summary of Ordinal VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Want to Use | 28 Participants |
| e-Vapor Product D | Summary of Ordinal VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Do Not Want to Use | 4 Participants |
| e-Vapor Product D | Summary of Ordinal VAS-Derived Categorical Use Product Again Questionnaire Scores by Test Product | Don't Care | 0 Participants |
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
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Summary Statistics of Puff Count by Test Product During the Ad Libitum-Use Sessions | 292.375 puffs | Standard Deviation 204.2479 |
| e-Vapor Product B | Summary Statistics of Puff Count by Test Product During the Ad Libitum-Use Sessions | 239.000 puffs | Standard Deviation 164.4613 |
| e-Vapor Product C | Summary Statistics of Puff Count by Test Product During the Ad Libitum-Use Sessions | 246.375 puffs | Standard Deviation 170.3419 |
| e-Vapor Product D | Summary Statistics of Puff Count by Test Product During the Ad Libitum-Use Sessions | 242.839 puffs | Standard Deviation 194.6732 |
Comparison: Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0p-value: <0.000195% CI: [213.62, 341.96]ANCOVA
Comparison: Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0p-value: <0.000195% CI: [176.99, 305.64]ANCOVA
Comparison: Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0p-value: <0.000195% CI: [184.01, 312.43]ANCOVA
Comparison: Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0p-value: <0.000195% CI: [193.58, 322.26]ANCOVA
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
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Summary Statistics of Total Cartridge Weight Change by Test Product, Per Subject, During the Ad Libitum-Use Sessions | 0.534 Grams | Standard Deviation 0.43562 |
| e-Vapor Product B | Summary Statistics of Total Cartridge Weight Change by Test Product, Per Subject, During the Ad Libitum-Use Sessions | 0.406 Grams | Standard Deviation 0.32699 |
| e-Vapor Product C | Summary Statistics of Total Cartridge Weight Change by Test Product, Per Subject, During the Ad Libitum-Use Sessions | 0.469 Grams | Standard Deviation 0.36765 |
| e-Vapor Product D | Summary Statistics of Total Cartridge Weight Change by Test Product, Per Subject, During the Ad Libitum-Use Sessions | 0.418 Grams | Standard Deviation 0.3312 |
Comparison: Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.p-value: <0.000195% CI: [0.407, 0.665]ANCOVA
Comparison: Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.p-value: <0.000195% CI: [0.28, 0.537]ANCOVA
Comparison: Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.p-value: <0.000195% CI: [0.339, 0.596]ANCOVA
Comparison: Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.p-value: <0.000195% CI: [0.301, 0.559]ANCOVA
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
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Total Cartridges Used by Test Product During the Ad Libitum-Use Sessions | 1.313 Cartridges | Standard Deviation 0.59229 |
| e-Vapor Product B | Total Cartridges Used by Test Product During the Ad Libitum-Use Sessions | 1.219 Cartridges | Standard Deviation 0.49084 |
| e-Vapor Product C | Total Cartridges Used by Test Product During the Ad Libitum-Use Sessions | 1.219 Cartridges | Standard Deviation 0.49084 |
| e-Vapor Product D | Total Cartridges Used by Test Product During the Ad Libitum-Use Sessions | 1.129 Cartridges | Standard Deviation 0.34078 |
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.
Time frame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Population: Cartridges of products utilized by participants during 12-hour ad-libitum-use session
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| e-Vapor Product A | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 418.433 Seconds | Standard Deviation 293.8095 |
| e-Vapor Product A | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 597.673 Seconds | Standard Deviation 366.5793 |
| e-Vapor Product A | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 3 | 315.777 Seconds | Standard Deviation 127.2806 |
| e-Vapor Product A | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 548.948 Seconds | Standard Deviation 352.5085 |
| e-Vapor Product B | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 491.003 Seconds | Standard Deviation 309.3294 |
| e-Vapor Product B | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 455.996 Seconds | Standard Deviation 299.0212 |
| e-Vapor Product B | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 567.524 Seconds | Standard Deviation 247.0947 |
| e-Vapor Product B | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 3 | 1158.612 Seconds | Standard Deviation 0 |
| e-Vapor Product C | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 414.832 Seconds | Standard Deviation 411.0123 |
| e-Vapor Product C | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 482.433 Seconds | Standard Deviation 288.8387 |
| e-Vapor Product C | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 3 | 682.752 Seconds | Standard Deviation 0 |
| e-Vapor Product C | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 486.874 Seconds | Standard Deviation 274.7173 |
| e-Vapor Product D | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 456.823 Seconds | Standard Deviation 278.4626 |
| e-Vapor Product D | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 463.815 Seconds | Standard Deviation 273.8106 |
| e-Vapor Product D | Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 404.380 Seconds | Standard Deviation 352.2326 |
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
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Total Puff Duration by Test Product During the Ad Libitum-Use Sessions | 726.028 Seconds | Standard Deviation 551.0662 |
| e-Vapor Product B | Total Puff Duration by Test Product During the Ad Libitum-Use Sessions | 589.204 Seconds | Standard Deviation 435.7242 |
| e-Vapor Product C | Total Puff Duration by Test Product During the Ad Libitum-Use Sessions | 575.807 Seconds | Standard Deviation 442.4253 |
| e-Vapor Product D | Total Puff Duration by Test Product During the Ad Libitum-Use Sessions | 517.733 Seconds | Standard Deviation 386.5348 |
Comparison: Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0p-value: <0.000195% CI: [549.19, 870.54]ANCOVA
Comparison: Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0p-value: <0.000195% CI: [407.18, 729.51]ANCOVA
Comparison: Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0p-value: <0.000195% CI: [401.34, 722.67]ANCOVA
Comparison: Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0p-value: <0.000195% CI: [356.11, 678.34]ANCOVA
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.
Time frame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Population: Cartridges of products utilized by participants during 12-hour ad-libitum-use session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Total Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 814.728 Seconds | Standard Deviation 350.9879 |
| e-Vapor Product B | Total Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 432.943 Seconds | Standard Deviation 240.6142 |
| e-Vapor Product C | Total Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 766.922 Seconds | Standard Deviation 307.3669 |
| e-Vapor Product D | Total Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 729.328 Seconds | Standard Deviation 317.4452 |
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.
Time frame: 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)
Population: Cartridges of products utilized by participants during 12-hour ad-libitum-use session
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| e-Vapor Product A | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 0.351 Grams | Standard Deviation 0.25264 |
| e-Vapor Product A | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 0.407 Grams | Standard Deviation 0.25716 |
| e-Vapor Product A | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 0.428 Grams | Standard Deviation 0.26613 |
| e-Vapor Product A | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 3 | 0.293 Grams | Standard Deviation 0.0601 |
| e-Vapor Product B | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 0.310 Grams | Standard Deviation 0.22996 |
| e-Vapor Product B | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 0.333 Grams | Standard Deviation 0.24023 |
| e-Vapor Product B | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 0.381 Grams | Standard Deviation 0.24206 |
| e-Vapor Product B | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 3 | 0.812 Grams | Standard Deviation 0 |
| e-Vapor Product C | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 3 | 0.444 Grams | Standard Deviation 0 |
| e-Vapor Product C | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 0.385 Grams | Standard Deviation 0.2491 |
| e-Vapor Product C | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 0.398 Grams | Standard Deviation 0.25131 |
| e-Vapor Product C | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 0.309 Grams | Standard Deviation 0.267 |
| e-Vapor Product D | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 1 | 0.369 Grams | Standard Deviation 0.23418 |
| e-Vapor Product D | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Overall | 0.370 Grams | Standard Deviation 0.22882 |
| e-Vapor Product D | Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions | Cartridge 2 | 0.383 Grams | Standard Deviation 0.21158 |
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.
Time frame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Population: Cartridges of products utilized by participants during 12-hour ad-libitum-use session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| e-Vapor Product A | Total Weight Change by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 0.623 Grams | Standard Deviation 0.24705 |
| e-Vapor Product B | Total Weight Change by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 0.315 Grams | Standard Deviation 0.18197 |
| e-Vapor Product C | Total Weight Change by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 0.664 Grams | Standard Deviation 0.19375 |
| e-Vapor Product D | Total Weight Change by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions | 0.656 Grams | Standard Deviation 0.15309 |