Tobacco Use
Conditions
Brief summary
The purpose of this study was to estimate changes in biomarkers of exposure (BOE) in adult cigarette smokers using an oral tobacco-derived nicotine (OTDN) product relative to adult smokers who continue smoking exclusively.
Detailed description
This was a randomized, controlled, open-label, parallel group, multicenter, 9-week study to determine changes in BOE in adult smokers allowed ad libitum use of an OTDN product relative to adult smokers who were not allowed to use an OTDN product. This study was conducted in adult smokers who were considered to be in overall good health. Subjects were randomized to Test (allowed OTDN use) or Control (not allowed OTDN use) groups.
Interventions
OTHEROral tobacco-derived nicotine product (OTDN)
Sponsors
Altria Client Services LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Subject must: 1. sign an 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. 3. have consumed a minimum of 10 manufactured cigarettes per day (CPD) daily during the last 6 months (entire 6 month period must have occurred after subject turned 21 years of age). 4. indicate that he/she smokes cigarettes every day at Screening and on Day 1 5. be able to fully comprehend the English language. 6. have an active phone number and must have daily access to a touchtone phone between 1600 and 1900 hours. 7. be interested in alternative tobacco products to cigarettes at Screening. 8. indicate that they definitely would buy or probably would buy on the VBM-FG2 Potential Purchase Interest Questionnaire. 9. be in generally good health. 10. if female, have a negative urine dipstick pregnancy test. 11. if female heterosexually active and of childbearing potential (i.e., not surgically sterile or two years naturally postmenopausal), agree to use a medically accepted method of contraception from Screening through the End of Study. 12. have clinical laboratory tests within the appropriate reference range or which are clinically acceptable to the Investigator. 13. have a negative ethanol, amphetamines, opiates, cannabinoids, and cocaine urine drug screen. 14. test negative for human immunodeficiency (HIV), hepatitis B (hepatitis B surface antigen \[HBsAg\]), and Hepatitis C (anti-hepatitis C virus antibody \[anti-HCV\]). 15. be willing and able to comply with the requirements of the study.
Exclusion criteria
Subject must not: 1. be pregnant, nursing, or planning to become pregnant during the study period. 2. indicate that he/she intends to quit smoking within the next 30 days (at Screening or on Day 1). 3. have uncontrolled hypertension, history of coronary heart disease or other significant heart conditions, and/or other significant medical conditions that might interfere with study procedures. 4. have used prescription anti-diabetic medication and/or insulin therapy within 12 months of Day 1. 5. have a history of drug or alcohol abuse within the 24 months prior to Screening. 6. have participated in a clinical study for an investigational drug, device, or biologic within 30 days prior to enrollment (Day 1). 7. be a current user of nicotine replacement therapy (indicate every day or some days on Subject Screener/Tobacco History Questionnaire). 8. be a current or former employee of the tobacco industry or a first-degree relative (e.g., parent, sibling, child) of a current or former employee of the tobacco industry. 9. have been involved in the development of the study design/conduct or be a first-degree relative (e.g., parent, sibling, child) of someone involved in the development of the study design/conduct. 10. be a current employee or personnel involved with the study at the study site. 11. be currently participating in the study at a different study site (i.e., each subject can only be in the study population once).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population) | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Summary statistics of percent change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \[NNAL\] (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a Statistical Analysis System (SAS®) procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population) | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Summary statistics of change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (mg/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 |
| Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population) | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Summary statistics of percent change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure. |
| Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population) | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Summary statistics of change from Baseline for urinary S-phenyl mercapturic acid \[S-PMA\] (ng/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 |
| Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population) | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Summary statistics of percent change from Baseline for urinary S-phenyl mercapturic acid \[S-PMA\] (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure. |
| Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Summary statistics of change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 |
| Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Summary statistics of percent change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure. |
| Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population) | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Summary statistics of change from Baseline for exhaled carbon monoxide (ppm) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 |
| Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population) | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Summary statistics of percent change from Baseline for exhaled carbon monoxide (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure. |
| Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population) | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Summary statistics of change from Baseline in number or products used day in each study visit are presented. Values for visit are the average of daily values for the previous week Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 |
| Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population) | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Summary statistics of percent change from Baseline of number of products used per day in each study visit are presented. CPD was tracked using an interactive voice response system (IVRS). During the Baseline Period (Days 1 to 8), subjects reported CPD daily through an IVRS each day between 16:00 and 19:00. Test and Control subjects continued daily tobacco use tracking via an IVRS and return to the study site once a week during the 4 week Product Use Period on Days 15, 22, 29, and 36. Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing the calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS procedure. |
| Summary Statistics of Change From Baseline for Total Score of Fagerstrom Test for Cigarette Dependence (Per-Protocol Population) | Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Summary statistics of change from Baseline for Total Score of Fagerstrom Test for Cigarette Dependence at the end of study/early termination are presented. The Fagerstrom Test for Nicotine Dependence consists of Yes/No and multiple-choice questions where each response is assigned a value from 0 to 1 (for yes/no questions) or 0 to 3 (for multiple-choice questions). Values are summed to yield a total score with a minimum score of 0 points and a maximum score of 10 points. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. Baseline = Visit 3 (Day 8) value Population: Per-Protocol |
| Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quit Attempts (Per-Protocol) | Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Count of Test and Control subjects that reported an increase, decrease or no change in quit attempts from Baseline to End of Study are presented. Results for the number of self-reported attempts to quit smoking in the previous 30 days were collected from subject responses to the question How many times during the past 30 days have you stopped smoking cigarettes for 24 hours or longer because you were trying to quit?. Baseline = Visit 2 values. Population: Per-Protocol. |
| Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quitting Intentions (Per-Protocol) | Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Count of Test and Control subjects that reported a change (No to Yes) or no change in quitting intentions from Baseline to End of Study are presented. Results were collected from subject Yes/No responses to the question Are you planning to quit smoking in the next 30 days?. Baseline = Visit 2 responses. Population: Per-Protocol. |
| Difference in Means of Urinary Total NNAL Exposure Between Day 1 and Day 8 (Per-Protocol) | Daily during Baseline Period (Day 1 to Day 8) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary total NNAL exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol. |
| Difference in Means of Nicotine Equivalents Exposure Between Day 1 and Day 8 (Per-Protocol) | Daily during Baseline Period (Day 1 to Day 8) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary nicotine equivalents exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) Population: Per-Protocol. |
| Difference in Means of S-PMA Exposure Between Day 1 and Day 8 (Per-Protocol) | Daily during Baseline Period (Day 1 to Day 8) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary S-phenylmercapturic acid \[S-PMA\] exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol. |
| Difference in Means of Carboxyhemoglobin (COHb) Exposure Between Day 1 and Day 8 (Per-Protocol) | Daily during Baseline Period (Day 1 to Day 8) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean blood carboxyhemoglobin \[COHb\] exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol. |
| Difference in Means of Carbon Monoxide (CO) Exposure Between Day 1 and Day 8 (Per-Protocol) | Daily during Baseline Period (Day 1 to Day 8) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean exhaled carbon monoxide \[CO\] between two methods for determining daily product use (Cigarettes Per Day, CPD) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol. |
| Difference in Cigarettes Per Day Between the Once Weekly Recall at Day 8 (From Questionnaire) and the Average Daily Tracking Days 2 Through 8 (From IVRS) (Per-Protocol) | Daily during Baseline Period (Day 1 to Day 8) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in product use (Cigarettes Per Day \[CPD\]), including test product, between two methods for determining CPD during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol. |
| Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7) | Change in cigarette consumption, categorized as 'No change', '\<50% reduction', '50% to \< 100% reduction', '100% reduction' or 'Increase', among subjects in Test and Control groups are presented. Baseline values are based on the average of daily values for the week prior to randomization (Visit 3/Day 8±1). |
| Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7) | Change in Urinary Total NNAL, categorized as 'No change', 'Reduction', 'Increase' or 'Missing', among subjects in Test and Control groups are presented. Baseline values are Visit 3 (Day 8) values. |
| Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions | Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Change in subject quitting intentions from Baseline to End of Study are presented. Subject responses were categorized as 'No to Yes', 'Yes to No' and 'Same' (no change in quitting intention). Baseline = Visit 2 (Day 1) |
| Summary Statistics of Cigarettes Smoked Per Day on Visits 2 (Day 1) and 3 (Day 8) | Day 1 (Visit 2) and Day 8 (Visit 3) | Summary statistics of average cigarettes smoked per day \[CPD\] over previous 7 days collected from Cigarette Use questionnaire on Visit 2 (Day 1) and Visit 3 (Day 8) are presented. |
| Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7) | Summary statistics of blood carboxyhemoglobin in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. |
| Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7) | Summary Statistics of exhaled carbon monoxide in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. |
| Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7) | Summary statistics of urinary S-PMA (ng/g creatinine) in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. |
| Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | Day 1 (Visit 2) and Day 8 (Visit 3) | Descriptive statistics for Cigarettes Smoked per Day (CPD) in Day 1 (Visit 2) and Day 8 (Visit 3) in Test and Control groups using recall data are presented. Subjects were sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing'). |
| Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Daily during Baseline Period (Day 1 to Day 8) | Summary Statistics of Cigarettes Smoked per Day collected by IVRS Data method on Days 1 to 8 for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. |
| Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group | Day 8 (Visit 3) and End of Study (Day 36±1) | Median change from baseline to End of Study for urinary total NNAL in Test and Control groups are presented. Baseline = Day 8 (Visit 3) values. |
| Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) | Median Change from baseline to End of Study for urinary total NNAL in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Day 8 (Visit 3) values |
| Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) | Change from Baseline to End of Study summary statistics of urinary total NNAL (ng/g Creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. |
| Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) | Percent change from Baseline to End of study summary statistics of urinary total NNAL (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. |
| Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) | Change from Baseline to End of Study summary statistics of urinary nicotine equivalents (mg/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide). Baseline = Visit 3 (Day 8) values. |
| Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) | Percent change from Baseline to End of study summary statistics of urinary nicotine equivalents (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide). Baseline = Visit 3 (Day 8) values. |
| Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) | Change from Baseline to End of Study summary statistics of urinary S-phenyl mercapturic acid \[S-PMA\] (ng/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. |
| Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) | Percent change from Baseline to End of study summary statistics of urinary S-phenyl mercapturic acid \[S-PMA\] (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. |
| Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population) | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Summary statistics of change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \[NNAL\] (ng/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 |
| Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) | Percent change from Baseline to End of study summary statistics of blood carboxyhemoglobin (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. |
| Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) | Change from Baseline to End of Study summary statistics of exhaled carbon monoxide (ppm) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. |
| Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) | Percent change from Baseline to End of study summary statistics of exhaled carbon monoxide for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. |
| Characterization of Subgroups Based on Change From Baseline in Total NNAL | Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) | Statistical analyses on the number of subjects in subgroups based on urinary total NNAL change from baseline to the last visit are presented. Baseline = Visit 3 values. |
| Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) | Change from Baseline to End of Study summary statistics of blood carboxyhemoglobin (%) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. |
Countries
United States
Participant flow
Pre-assignment details
Subjects were required to complete an 8 day baseline assessment during which subject cigarette use data was collected using daily interactive voice response system (IVRS) calls and recall of the previous week methods. Three subjects were withdrawn from the study prior to randomization. A total of 154 subjects were randomized in this study; 92 subjects were randomized to the Test Group and 62 subjects were randomized to the Control Group.
Participants by arm
| Arm | Count |
|---|---|
| Test (ad Libitum VBM-FG2) Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions | 92 |
| Control (no VBM-FG2) Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks | 62 |
| Total | 154 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Control (no VBM-FG2) | Total | Test (ad Libitum VBM-FG2) |
|---|---|---|---|
| Age, Continuous | 42 years | 43 years | 43 years |
| BMI | 29.0 kg/m^2 STANDARD_DEVIATION 7.26 | 28.6 kg/m^2 STANDARD_DEVIATION 6.91 | 28.3 kg/m^2 STANDARD_DEVIATION 6.69 |
| Body Weight | 85.3 kg STANDARD_DEVIATION 23.56 | 83.8 kg STANDARD_DEVIATION 21.99 | 82.8 kg STANDARD_DEVIATION 20.94 |
| Cigarette Consumption per Day ≤ 20 | 44 Participants | 110 Participants | 66 Participants |
| Cigarette Consumption per Day >20 | 18 Participants | 44 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 9 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants | 145 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 171.1 cm STANDARD_DEVIATION 9.4 | 170.9 cm STANDARD_DEVIATION 8.75 | 170.8 cm STANDARD_DEVIATION 8.32 |
| Number of years smoked since turning 21 years of age | 20.3 years STANDARD_DEVIATION 10.3 | 19.8 years STANDARD_DEVIATION 10.69 | 19.5 years STANDARD_DEVIATION 10.99 |
| Quit Attempts No | 59 Participants | 148 Participants | 89 Participants |
| Quit Attempts Yes | 3 Participants | 6 Participants | 3 Participants |
| Quit Attempts in previous 6 months | 0.2 smoking cessations STANDARD_DEVIATION 0.67 | 0.3 smoking cessations STANDARD_DEVIATION 0.81 | 0.3 smoking cessations STANDARD_DEVIATION 0.89 |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black or African American | 11 Participants | 26 Participants | 15 Participants |
| Race/Ethnicity, Customized Race Other | 4 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized Race White | 47 Participants | 119 Participants | 72 Participants |
| Sex: Female, Male Female | 30 Participants | 78 Participants | 48 Participants |
| Sex: Female, Male Male | 32 Participants | 76 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 62 |
| other Total, other adverse events | 25 / 92 | 7 / 62 |
| serious Total, serious adverse events | 0 / 92 | 0 / 62 |
Outcome results
Primary
Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population)
Summary statistics of percent change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \[NNAL\] (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a Statistical Analysis System (SAS®) procedure.
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population. All Per-Protocol Test and Control subjects were included in the analysis. If a value was missing for any subject at any visit, that subject's value was omitted from the analysis for that visit only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population) | Visit 4 | 3.8 percent change from baseline | Standard Deviation 34.11 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population) | Visit 5 | 12.5 percent change from baseline | Standard Deviation 60.16 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population) | Visit 6 | 16.0 percent change from baseline | Standard Deviation 50.87 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population) | End of Study/Early Termination | 15.4 percent change from baseline | Standard Deviation 62.42 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population) | End of Study/Early Termination | 28.4 percent change from baseline | Standard Deviation 57.66 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population) | Visit 4 | 13.8 percent change from baseline | Standard Deviation 45.56 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population) | Visit 6 | 29.2 percent change from baseline | Standard Deviation 46.7 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population) | Visit 5 | 30.4 percent change from baseline | Standard Deviation 63.66 |
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNALp-value: 0.234795% CI: [-33.5, 8.27]t-test, 2 sided
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNALp-value: 0.290595% CI: [-33.9, 10.2]t-test, 2 sided
Secondary
Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits
Change from Baseline to End of Study summary statistics of blood carboxyhemoglobin (%) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 4.45 percent saturation of carboxyhemoglobin | Standard Deviation 0.354 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5.40 percent saturation of carboxyhemoglobin | Standard Deviation 1.918 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6.62 percent saturation of carboxyhemoglobin | Standard Deviation 2.151 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 5.68 percent saturation of carboxyhemoglobin | Standard Deviation 2.153 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 4.25 percent saturation of carboxyhemoglobin | Standard Deviation 2.333 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 5.36 percent saturation of carboxyhemoglobin | Standard Deviation 2.159 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.53 percent saturation of carboxyhemoglobin | Standard Deviation 1.986 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 4.99 percent saturation of carboxyhemoglobin | Standard Deviation 2.184 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5.31 percent saturation of carboxyhemoglobin | Standard Deviation 1.627 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.11 percent saturation of carboxyhemoglobin | Standard Deviation 1.897 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 3.65 percent saturation of carboxyhemoglobin | Standard Deviation 2.192 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 4.91 percent saturation of carboxyhemoglobin | Standard Deviation 2.071 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 3.65 percent saturation of carboxyhemoglobin | Standard Deviation 0.919 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 5.00 percent saturation of carboxyhemoglobin | Standard Deviation 1.278 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5.97 percent saturation of carboxyhemoglobin | Standard Deviation 1.803 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 1.45 percent saturation of carboxyhemoglobin | Standard Deviation 0.212 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5.11 percent saturation of carboxyhemoglobin | Standard Deviation 2.066 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 3.21 percent saturation of carboxyhemoglobin | Standard Deviation 1.87 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 4.60 percent saturation of carboxyhemoglobin | Standard Deviation 1.414 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.00 percent saturation of carboxyhemoglobin | Standard Deviation 1.821 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5.39 percent saturation of carboxyhemoglobin | Standard Deviation 1.786 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 4.57 percent saturation of carboxyhemoglobin | Standard Deviation 1.847 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | -0.29 percent saturation of carboxyhemoglobin | Standard Deviation 1.323 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | -0.65 percent saturation of carboxyhemoglobin | Standard Deviation 1.099 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | -0.68 percent saturation of carboxyhemoglobin | Standard Deviation 1.342 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | -2.15 percent saturation of carboxyhemoglobin | Standard Deviation 0.952 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | -3.00 percent saturation of carboxyhemoglobin | Standard Deviation 0.141 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | -0.60 percent saturation of carboxyhemoglobin | Standard Deviation 1.414 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | -0.61 percent saturation of carboxyhemoglobin | Standard Deviation 1.387 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 0.95 percent saturation of carboxyhemoglobin | Standard Deviation 0.778 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 0.09 percent saturation of carboxyhemoglobin | Standard Deviation 1.178 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | -0.10 percent saturation of carboxyhemoglobin | Standard Deviation 1.118 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | -0.42 percent saturation of carboxyhemoglobin | Standard Deviation 0.986 |
Secondary
Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits
Change from Baseline to End of Study summary statistics of exhaled carbon monoxide (ppm) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 17.00 ppm | Standard Deviation 4.243 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 21.32 ppm | Standard Deviation 10.133 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 29.64 ppm | Standard Deviation 12.118 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 22.50 ppm | Standard Deviation 9.562 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 18.50 ppm | Standard Deviation 16.263 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 20.63 ppm | Standard Deviation 9.855 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 22.24 ppm | Standard Deviation 10.491 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 20.96 ppm | Standard Deviation 11.126 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 20.59 ppm | Standard Deviation 9.109 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 20.42 ppm | Standard Deviation 10.046 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 11.50 ppm | Standard Deviation 10.607 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 20.15 ppm | Standard Deviation 10.41 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 13.00 ppm | Standard Deviation 8.485 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 21.50 ppm | Standard Deviation 9.957 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 25.91 ppm | Standard Deviation 8.86 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 4.00 ppm | Standard Deviation 2.828 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 21.13 ppm | Standard Deviation 10.091 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 9.88 ppm | Standard Deviation 6.081 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 18.50 ppm | Standard Deviation 2.121 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 19.65 ppm | Standard Deviation 8.939 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 20.21 ppm | Standard Deviation 9.537 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 19.08 ppm | Standard Deviation 8.707 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | -0.46 ppm | Standard Deviation 8.466 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Increase | -3.73 ppm | Standard Deviation 10.248 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | No Change | -1.00 ppm | Standard Deviation 9.798 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | -10.75 ppm | Standard Deviation 8.172 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | -13.00 ppm | Standard Deviation 1.414 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Missing | -5.50 ppm | Standard Deviation 7.778 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Overall | -2.28 ppm | Standard Deviation 9.175 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 7.00 ppm | Standard Deviation 8.485 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Increase | -0.38 ppm | Standard Deviation 7.894 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Overall | -0.76 ppm | Standard Deviation 6.899 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | -1.88 ppm | Standard Deviation 5.102 |
Secondary
Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits
Change from Baseline to End of Study summary statistics of urinary nicotine equivalents (mg/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide). Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 8.19 mg/g | Standard Deviation 1.87 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 15.00 mg/g | Standard Deviation 9.726 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 18.24 mg/g | Standard Deviation 14.941 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 8.75 mg/g | Standard Deviation 4.809 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 9.09 mg/g | Standard Deviation 1.956 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 11.51 mg/g | Standard Deviation 6.995 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 14.32 mg/g | Standard Deviation 9.996 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 14.77 mg/g | Standard Deviation 10.432 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 13.70 mg/g | Standard Deviation 7.87 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 14.06 mg/g | Standard Deviation 8.973 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 8.14 mg/g | — |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 16.60 mg/g | Standard Deviation 13.108 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 8.81 mg/g | Standard Deviation 0.629 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 10.23 mg/g | Standard Deviation 3.053 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 24.84 mg/g | Standard Deviation 14.892 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 7.41 mg/g | — |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 16.07 mg/g | Standard Deviation 11.551 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 16.62 mg/g | Standard Deviation 22.808 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 13.62 mg/g | Standard Deviation 1.6 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 17.13 mg/g | Standard Deviation 11.092 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 16.55 mg/g | Standard Deviation 6.791 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 18.07 mg/g | Standard Deviation 14.909 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 1.80 mg/g | Standard Deviation 9.214 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6.77 mg/g | Standard Deviation 7.432 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 1.48 mg/g | Standard Deviation 3.418 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 4.89 mg/g | Standard Deviation 20.082 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | -2.11 mg/g | — |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Missing | -0.28 mg/g | Standard Deviation 2.585 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 2.59 mg/g | Standard Deviation 9.748 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 6.61 mg/g | — |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 3.73 mg/g | Standard Deviation 5.932 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 3.59 mg/g | Standard Deviation 6.886 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 3.29 mg/g | Standard Deviation 8.011 |
Secondary
Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits
Change from Baseline to End of Study summary statistics of urinary S-phenyl mercapturic acid \[S-PMA\] (ng/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 5510.19 ng/g | Standard Deviation 123.439 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 6495.06 ng/g | Standard Deviation 5936.803 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5731.61 ng/g | Standard Deviation 5064.881 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 4216.93 ng/g | Standard Deviation 2660.723 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 2693.13 ng/g | Standard Deviation 1334.197 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 5352.66 ng/g | Standard Deviation 8413.472 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5991.56 ng/g | Standard Deviation 5741.49 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5356.63 ng/g | Standard Deviation 5359.524 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 4934.00 ng/g | Standard Deviation 4812.35 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5195.78 ng/g | Standard Deviation 4999.201 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 6930.38 ng/g | Standard Deviation 5483.666 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 7098.86 ng/g | Standard Deviation 7113.465 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 2896.76 ng/g | Standard Deviation 1518.588 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 4352.99 ng/g | Standard Deviation 3873.342 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 8389.80 ng/g | Standard Deviation 6625.523 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 440.59 ng/g | Standard Deviation 225.383 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 7335.57 ng/g | Standard Deviation 7068.643 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 9795.94 ng/g | Standard Deviation 12602.08 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 8688.22 ng/g | Standard Deviation 3272.243 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 6502.50 ng/g | Standard Deviation 5540.461 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6358.61 ng/g | Standard Deviation 5253.083 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 6481.35 ng/g | Standard Deviation 6132.009 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 875.52 ng/g | Standard Deviation 4755.856 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 2410.02 ng/g | Standard Deviation 2986.346 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 136.06 ng/g | Standard Deviation 3959.381 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 1941.73 ng/g | Standard Deviation 11042.4 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | -5069.60 ng/g | Standard Deviation 101.944 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 203.64 ng/g | Standard Deviation 184.391 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 903.49 ng/g | Standard Deviation 4985.072 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 1757.84 ng/g | Standard Deviation 2211.423 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 1341.70 ng/g | Standard Deviation 2495.655 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 1160.48 ng/g | Standard Deviation 2798.644 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 903.68 ng/g | Standard Deviation 3218.825 |
Secondary
Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits
Change from Baseline to End of Study summary statistics of urinary total NNAL (ng/g Creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 158.65 ng/g | Standard Deviation 2.244 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 535.46 ng/g | Standard Deviation 393.698 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 551.02 ng/g | Standard Deviation 318.27 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 456.39 ng/g | Standard Deviation 275.603 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 303.45 ng/g | Standard Deviation 252.531 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 443.02 ng/g | Standard Deviation 343.687 |
| Test (ad Libitum VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 507.43 ng/g | Standard Deviation 365.172 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 487.20 ng/g | Standard Deviation 378.047 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 440.36 ng/g | Standard Deviation 261.806 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 473.50 ng/g | Standard Deviation 347.581 |
| Control (no VBM-FG2) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 789.56 ng/g | Standard Deviation 1039.9 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 586.29 ng/g | Standard Deviation 525.084 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 268.14 ng/g | Standard Deviation 172.499 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 389.46 ng/g | Standard Deviation 170.153 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 721.93 ng/g | Standard Deviation 327.377 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 28.69 ng/g | Standard Deviation 17.194 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 614.61 ng/g | Standard Deviation 517.499 |
| Test (Visit 5) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 592.73 ng/g | Standard Deviation 932.562 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 592.51 ng/g | Standard Deviation 741.128 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 563.30 ng/g | Standard Deviation 376.309 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 538.09 ng/g | Standard Deviation 287.478 |
| Control (Visit 5) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 590.28 ng/g | Standard Deviation 451.453 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 88.22 ng/g | Standard Deviation 320.921 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 158.11 ng/g | Standard Deviation 140.443 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | -66.92 ng/g | Standard Deviation 185.884 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 149.71 ng/g | Standard Deviation 713.457 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | -129.96 ng/g | Standard Deviation 14.95 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Missing | -35.31 ng/g | Standard Deviation 80.032 |
| Test (Visit 6) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 81.33 ng/g | Standard Deviation 345.11 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | No Change | -197.05 ng/g | Standard Deviation 298.772 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 92.60 ng/g | Standard Deviation 227.975 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 86.53 ng/g | Standard Deviation 209.749 |
| Control (Visit 6) | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 103.08 ng/g | Standard Deviation 170.772 |
Secondary
Characterization of Subgroups Based on Change From Baseline in Total NNAL
Statistical analyses on the number of subjects in subgroups based on urinary total NNAL change from baseline to the last visit are presented. Baseline = Visit 3 values.
Time frame: Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Characterization of Subgroups Based on Change From Baseline in Total NNAL | Increase | 46 Participants |
| Test (ad Libitum VBM-FG2) | Characterization of Subgroups Based on Change From Baseline in Total NNAL | Reduction | 38 Participants |
| Control (no VBM-FG2) | Characterization of Subgroups Based on Change From Baseline in Total NNAL | Increase | 36 Participants |
| Control (no VBM-FG2) | Characterization of Subgroups Based on Change From Baseline in Total NNAL | Reduction | 18 Participants |
Comparison: Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of studyp-value: 0.1661Cochran-Mantel-Haenszel
Comparison: Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of studyp-value: 0.2139Fisher Exact
Secondary
Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quit Attempts (Per-Protocol)
Count of Test and Control subjects that reported an increase, decrease or no change in quit attempts from Baseline to End of Study are presented. Results for the number of self-reported attempts to quit smoking in the previous 30 days were collected from subject responses to the question How many times during the past 30 days have you stopped smoking cigarettes for 24 hours or longer because you were trying to quit?. Baseline = Visit 2 values. Population: Per-Protocol.
Time frame: Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quit Attempts (Per-Protocol) | Increase | 4 Participants |
| Test (ad Libitum VBM-FG2) | Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quit Attempts (Per-Protocol) | No Change | 82 Participants |
| Test (ad Libitum VBM-FG2) | Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quit Attempts (Per-Protocol) | Decrease | 1 Participants |
| Control (no VBM-FG2) | Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quit Attempts (Per-Protocol) | Increase | 0 Participants |
| Control (no VBM-FG2) | Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quit Attempts (Per-Protocol) | No Change | 53 Participants |
| Control (no VBM-FG2) | Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quit Attempts (Per-Protocol) | Decrease | 2 Participants |
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of studyp-value: 0.216Fisher Exact
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of studyp-value: 0.0648Cochran-Mantel-Haenszel
Secondary
Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quitting Intentions (Per-Protocol)
Count of Test and Control subjects that reported a change (No to Yes) or no change in quitting intentions from Baseline to End of Study are presented. Results were collected from subject Yes/No responses to the question Are you planning to quit smoking in the next 30 days?. Baseline = Visit 2 responses. Population: Per-Protocol.
Time frame: Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quitting Intentions (Per-Protocol) | No to Yes | 12 Participants |
| Test (ad Libitum VBM-FG2) | Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quitting Intentions (Per-Protocol) | Same | 74 Participants |
| Control (no VBM-FG2) | Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quitting Intentions (Per-Protocol) | No to Yes | 5 Participants |
| Control (no VBM-FG2) | Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quitting Intentions (Per-Protocol) | Same | 45 Participants |
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change in quitting intentions from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quitting intentions from baseline to end of studyp-value: 0.5977Fisher Exact
Secondary
Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories
Descriptive statistics for Cigarettes Smoked per Day (CPD) in Day 1 (Visit 2) and Day 8 (Visit 3) in Test and Control groups using recall data are presented. Subjects were sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing').
Time frame: Day 1 (Visit 2) and Day 8 (Visit 3)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | 50% to < 100% Reduction | 16.0 cigarettes per day | Standard Deviation 6.54 |
| Test (ad Libitum VBM-FG2) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | <50% Reduction | 18.4 cigarettes per day | Standard Deviation 5.97 |
| Test (ad Libitum VBM-FG2) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | Overall | 17.7 cigarettes per day | Standard Deviation 6.04 |
| Test (ad Libitum VBM-FG2) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | Increase | 15.6 cigarettes per day | Standard Deviation 4.12 |
| Test (ad Libitum VBM-FG2) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | No Change | 19.5 cigarettes per day | Standard Deviation 8.8 |
| Test (ad Libitum VBM-FG2) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | Missing | 15.0 cigarettes per day | Standard Deviation 7.07 |
| Test (ad Libitum VBM-FG2) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | 100% Reduction | 12.5 cigarettes per day | Standard Deviation 3.54 |
| Control (no VBM-FG2) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | <50% Reduction | 19.8 cigarettes per day | Standard Deviation 6.96 |
| Control (no VBM-FG2) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | Overall | 19.8 cigarettes per day | Standard Deviation 7.64 |
| Control (no VBM-FG2) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | No Change | 20.0 cigarettes per day | Standard Deviation 0 |
| Control (no VBM-FG2) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | Increase | 19.7 cigarettes per day | Standard Deviation 8.52 |
| Test (Visit 5) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | Missing | 20.0 cigarettes per day | — |
| Test (Visit 5) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | Increase | 16.1 cigarettes per day | Standard Deviation 4.68 |
| Test (Visit 5) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | 50% to < 100% Reduction | 16.8 cigarettes per day | Standard Deviation 5.85 |
| Test (Visit 5) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | No Change | 17.6 cigarettes per day | Standard Deviation 8.28 |
| Test (Visit 5) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | 100% Reduction | 11.0 cigarettes per day | Standard Deviation 2.83 |
| Test (Visit 5) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | Overall | 17.6 cigarettes per day | Standard Deviation 5.36 |
| Test (Visit 5) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | <50% Reduction | 18.2 cigarettes per day | Standard Deviation 4.94 |
| Control (Visit 5) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | Overall | 20.0 cigarettes per day | Standard Deviation 7.43 |
| Control (Visit 5) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | Increase | 19.9 cigarettes per day | Standard Deviation 8.47 |
| Control (Visit 5) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | No Change | 20.0 cigarettes per day | Standard Deviation 0 |
| Control (Visit 5) | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | <50% Reduction | 20.2 cigarettes per day | Standard Deviation 6.36 |
Secondary
Difference in Cigarettes Per Day Between the Once Weekly Recall at Day 8 (From Questionnaire) and the Average Daily Tracking Days 2 Through 8 (From IVRS) (Per-Protocol)
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in product use (Cigarettes Per Day \[CPD\]), including test product, between two methods for determining CPD during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol.
Time frame: Daily during Baseline Period (Day 1 to Day 8)
Population: The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Difference in Cigarettes Per Day Between the Once Weekly Recall at Day 8 (From Questionnaire) and the Average Daily Tracking Days 2 Through 8 (From IVRS) (Per-Protocol) | 19 cigarettes per day | Standard Deviation 6.4 |
| Control (no VBM-FG2) | Difference in Cigarettes Per Day Between the Once Weekly Recall at Day 8 (From Questionnaire) and the Average Daily Tracking Days 2 Through 8 (From IVRS) (Per-Protocol) | 19 cigarettes per day | Standard Deviation 6.3 |
Comparison: Null hypothesis = Cigarette consumption (CPD) determined using the Day 1 (Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will be equivalent; Alternate hypothesis = Cigarette consumption (CPD) determined using the Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT be equivalentp-value: 0.999295% CI: [0, 0]t-test, 2 sided
Secondary
Difference in Means of Carbon Monoxide (CO) Exposure Between Day 1 and Day 8 (Per-Protocol)
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean exhaled carbon monoxide \[CO\] between two methods for determining daily product use (Cigarettes Per Day, CPD) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol.
Time frame: Daily during Baseline Period (Day 1 to Day 8)
Population: The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Difference in Means of Carbon Monoxide (CO) Exposure Between Day 1 and Day 8 (Per-Protocol) | 22 ppm | Standard Deviation 10 |
| Control (no VBM-FG2) | Difference in Means of Carbon Monoxide (CO) Exposure Between Day 1 and Day 8 (Per-Protocol) | 22 ppm | Standard Deviation 10.3 |
Comparison: Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carbon monoxide; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carbon monoxidep-value: 0.748495% CI: [-1, 1]t-test, 2 sided
Secondary
Difference in Means of Carboxyhemoglobin (COHb) Exposure Between Day 1 and Day 8 (Per-Protocol)
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean blood carboxyhemoglobin \[COHb\] exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol.
Time frame: Daily during Baseline Period (Day 1 to Day 8)
Population: The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Difference in Means of Carboxyhemoglobin (COHb) Exposure Between Day 1 and Day 8 (Per-Protocol) | 5.4 percent saturation of carboxyhemoglobin | Standard Deviation 2.13 |
| Control (no VBM-FG2) | Difference in Means of Carboxyhemoglobin (COHb) Exposure Between Day 1 and Day 8 (Per-Protocol) | 5.4 percent saturation of carboxyhemoglobin | Standard Deviation 1.96 |
Comparison: Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carboxyhemoglobin; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carboxyhemoglobinp-value: 0.94495% CI: [-0.2, 0.2]t-test, 2 sided
Secondary
Difference in Means of Nicotine Equivalents Exposure Between Day 1 and Day 8 (Per-Protocol)
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary nicotine equivalents exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) Population: Per-Protocol.
Time frame: Daily during Baseline Period (Day 1 to Day 8)
Population: The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Difference in Means of Nicotine Equivalents Exposure Between Day 1 and Day 8 (Per-Protocol) | 13.29 mg/g | Standard Deviation 9.138 |
| Control (no VBM-FG2) | Difference in Means of Nicotine Equivalents Exposure Between Day 1 and Day 8 (Per-Protocol) | 13.74 mg/g | Standard Deviation 9.049 |
Comparison: Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of nicotine metabolites; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of nicotine metabolitesp-value: 0.33995% CI: [-0.48, 1.38]t-test, 2 sided
Secondary
Difference in Means of S-PMA Exposure Between Day 1 and Day 8 (Per-Protocol)
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary S-phenylmercapturic acid \[S-PMA\] exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol.
Time frame: Daily during Baseline Period (Day 1 to Day 8)
Population: The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Difference in Means of S-PMA Exposure Between Day 1 and Day 8 (Per-Protocol) | 5773 ng/g | Standard Deviation 5786.3 |
| Control (no VBM-FG2) | Difference in Means of S-PMA Exposure Between Day 1 and Day 8 (Per-Protocol) | 5567 ng/g | Standard Deviation 5222.3 |
Comparison: Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of S-PMA; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of S-PMAp-value: 0.452695% CI: [-745, 334]t-test, 2 sided
Secondary
Difference in Means of Urinary Total NNAL Exposure Between Day 1 and Day 8 (Per-Protocol)
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary total NNAL exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol.
Time frame: Daily during Baseline Period (Day 1 to Day 8)
Population: The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Difference in Means of Urinary Total NNAL Exposure Between Day 1 and Day 8 (Per-Protocol) | 485.0 ng/g | Standard Deviation 348.45 |
| Control (no VBM-FG2) | Difference in Means of Urinary Total NNAL Exposure Between Day 1 and Day 8 (Per-Protocol) | 495.0 ng/g | Standard Deviation 358.54 |
Comparison: Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of NNAL; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of NNALp-value: 0.438895% CI: [-15.5, 35.5]t-test, 2 sided
Secondary
Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption
Change in cigarette consumption, categorized as 'No change', '\<50% reduction', '50% to \< 100% reduction', '100% reduction' or 'Increase', among subjects in Test and Control groups are presented. Baseline values are based on the average of daily values for the week prior to randomization (Visit 3/Day 8±1).
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)
Population: Per-protocol population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | No Change | 5 Participants |
| Test (ad Libitum VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | Increase | 12 Participants |
| Test (ad Libitum VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 100% Reduction | 0 Participants |
| Test (ad Libitum VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 50% to < 100% | 3 Participants |
| Test (ad Libitum VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | <50% Reduction | 67 Participants |
| Control (no VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | <50% Reduction | 22 Participants |
| Control (no VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 100% Reduction | 0 Participants |
| Control (no VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | Increase | 30 Participants |
| Control (no VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 50% to < 100% | 0 Participants |
| Control (no VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | No Change | 3 Participants |
| Test (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | <50% Reduction | 62 Participants |
| Test (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | Increase | 14 Participants |
| Test (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | No Change | 6 Participants |
| Test (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 100% Reduction | 2 Participants |
| Test (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 50% to < 100% | 3 Participants |
| Control (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 50% to < 100% | 0 Participants |
| Control (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | Increase | 30 Participants |
| Control (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | No Change | 4 Participants |
| Control (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | <50% Reduction | 21 Participants |
| Control (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 100% Reduction | 0 Participants |
| Test (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 50% to < 100% | 7 Participants |
| Test (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | No Change | 6 Participants |
| Test (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | <50% Reduction | 56 Participants |
| Test (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 100% Reduction | 1 Participants |
| Test (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | Increase | 17 Participants |
| Control (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 50% to < 100% | 0 Participants |
| Control (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 100% Reduction | 0 Participants |
| Control (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | <50% Reduction | 25 Participants |
| Control (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | No Change | 4 Participants |
| Control (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | Increase | 26 Participants |
| Test (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 50% to < 100% | 8 Participants |
| Test (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | No Change | 8 Participants |
| Test (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | <50% Reduction | 57 Participants |
| Test (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | Increase | 10 Participants |
| Test (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 100% Reduction | 2 Participants |
| Control (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | Increase | 29 Participants |
| Control (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 100% Reduction | 0 Participants |
| Control (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | No Change | 2 Participants |
| Control (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | 50% to < 100% | 0 Participants |
| Control (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | <50% Reduction | 24 Participants |
Secondary
Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions
Change in subject quitting intentions from Baseline to End of Study are presented. Subject responses were categorized as 'No to Yes', 'Yes to No' and 'Same' (no change in quitting intention). Baseline = Visit 2 (Day 1)
Time frame: Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions | No to Yes | 12 Participants |
| Test (ad Libitum VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions | Yes to No | 0 Participants |
| Test (ad Libitum VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions | Same | 74 Participants |
| Control (no VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions | No to Yes | 5 Participants |
| Control (no VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions | Yes to No | 0 Participants |
| Control (no VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions | Same | 45 Participants |
Secondary
Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine)
Change in Urinary Total NNAL, categorized as 'No change', 'Reduction', 'Increase' or 'Missing', among subjects in Test and Control groups are presented. Baseline values are Visit 3 (Day 8) values.
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)
Population: Per-protocol population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | No Change | 0 Participants |
| Test (ad Libitum VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Reduction | 45 Participants |
| Test (ad Libitum VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Increase | 35 Participants |
| Test (ad Libitum VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Missing | 7 Participants |
| Control (no VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Missing | 2 Participants |
| Control (no VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Reduction | 25 Participants |
| Control (no VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | No Change | 0 Participants |
| Control (no VBM-FG2) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Increase | 28 Participants |
| Test (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | No Change | 0 Participants |
| Test (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Missing | 4 Participants |
| Test (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Reduction | 40 Participants |
| Test (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Increase | 43 Participants |
| Control (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | No Change | 0 Participants |
| Control (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Reduction | 18 Participants |
| Control (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Increase | 33 Participants |
| Control (Visit 5) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Missing | 4 Participants |
| Test (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Missing | 8 Participants |
| Test (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Increase | 46 Participants |
| Test (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Reduction | 33 Participants |
| Test (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | No Change | 0 Participants |
| Control (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Missing | 2 Participants |
| Control (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Increase | 37 Participants |
| Control (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Reduction | 16 Participants |
| Control (Visit 6) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | No Change | 0 Participants |
| Test (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Missing | 3 Participants |
| Test (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | No Change | 0 Participants |
| Test (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Increase | 46 Participants |
| Test (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Reduction | 38 Participants |
| Control (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Reduction | 18 Participants |
| Control (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Increase | 36 Participants |
| Control (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Missing | 1 Participants |
| Control (End of Study) | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | No Change | 0 Participants |
Secondary
Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group
Median change from baseline to End of Study for urinary total NNAL in Test and Control groups are presented. Baseline = Day 8 (Visit 3) values.
Time frame: Day 8 (Visit 3) and End of Study (Day 36±1)
Population: Per-Protocol Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Test (ad Libitum VBM-FG2) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group | 472.893 ng/g |
| Control (no VBM-FG2) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group | 395.108 ng/g |
| Test (Visit 5) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group | 444.709 ng/g |
| Control (Visit 5) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group | 476.795 ng/g |
| Test (Visit 6) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group | 5.448 ng/g |
| Control (Visit 6) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group | 70.129 ng/g |
Secondary
Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories
Median Change from baseline to End of Study for urinary total NNAL in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Day 8 (Visit 3) values
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Increase | 548.817 ng/g |
| Test (ad Libitum VBM-FG2) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Missing | 303.452 ng/g |
| Test (ad Libitum VBM-FG2) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | <50% Reduction | 516.752 ng/g |
| Test (ad Libitum VBM-FG2) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Overall | 472.893 ng/g |
| Test (ad Libitum VBM-FG2) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | 100% Reduction | 158.649 ng/g |
| Test (ad Libitum VBM-FG2) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | No Change | 499.544 ng/g |
| Test (ad Libitum VBM-FG2) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | 50% to < 100% Reduction | 375.183 ng/g |
| Control (no VBM-FG2) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | <50% Reduction | 356.857 ng/g |
| Control (no VBM-FG2) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Overall | 395.108 ng/g |
| Control (no VBM-FG2) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Increase | 415.790 ng/g |
| Control (no VBM-FG2) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | No Change | 789.559 ng/g |
| Test (Visit 5) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | 100% Reduction | 28.686 ng/g |
| Test (Visit 5) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | 50% to < 100% Reduction | 263.677 ng/g |
| Test (Visit 5) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Increase | 719.799 ng/g |
| Test (Visit 5) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Overall | 444.709 ng/g |
| Test (Visit 5) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | No Change | 376.087 ng/g |
| Test (Visit 5) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Missing | 268.140 ng/g |
| Test (Visit 5) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | <50% Reduction | 444.709 ng/g |
| Control (Visit 5) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | <50% Reduction | 467.615 ng/g |
| Control (Visit 5) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Increase | 489.729 ng/g |
| Control (Visit 5) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | No Change | 592.508 ng/g |
| Control (Visit 5) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Overall | 476.795 ng/g |
| Test (Visit 6) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | 50% to < 100% Reduction | -48.425 ng/g |
| Test (Visit 6) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | <50% Reduction | 1.776 ng/g |
| Test (Visit 6) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | 100% Reduction | -129.963 ng/g |
| Test (Visit 6) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | No Change | 30.576 ng/g |
| Test (Visit 6) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Missing | -35.312 ng/g |
| Test (Visit 6) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Increase | 168.889 ng/g |
| Test (Visit 6) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Overall | 5.448 ng/g |
| Control (Visit 6) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | No Change | -197.051 ng/g |
| Control (Visit 6) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | <50% Reduction | 73.507 ng/g |
| Control (Visit 6) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Overall | 70.129 ng/g |
| Control (Visit 6) | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Increase | 67.998 ng/g |
Secondary
Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits
Percent change from Baseline to End of study summary statistics of blood carboxyhemoglobin (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 4.45 percent change from baseline | Standard Deviation 0.354 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5.40 percent change from baseline | Standard Deviation 1.918 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6.62 percent change from baseline | Standard Deviation 2.151 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 5.68 percent change from baseline | Standard Deviation 2.153 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 4.25 percent change from baseline | Standard Deviation 2.333 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 5.36 percent change from baseline | Standard Deviation 2.159 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.53 percent change from baseline | Standard Deviation 1.986 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 4.99 percent change from baseline | Standard Deviation 2.184 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5.31 percent change from baseline | Standard Deviation 1.627 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.11 percent change from baseline | Standard Deviation 1.897 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 3.65 percent change from baseline | Standard Deviation 2.192 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 4.91 percent change from baseline | Standard Deviation 2.071 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 3.65 percent change from baseline | Standard Deviation 0.919 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 5.00 percent change from baseline | Standard Deviation 1.278 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5.97 percent change from baseline | Standard Deviation 1.803 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 1.45 percent change from baseline | Standard Deviation 0.212 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5.11 percent change from baseline | Standard Deviation 2.066 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 3.21 percent change from baseline | Standard Deviation 1.87 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 4.60 percent change from baseline | Standard Deviation 1.414 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.00 percent change from baseline | Standard Deviation 1.821 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5.39 percent change from baseline | Standard Deviation 1.786 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 4.57 percent change from baseline | Standard Deviation 1.847 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | -3.7 percent change from baseline | Standard Deviation 25.91 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | -7.6 percent change from baseline | Standard Deviation 17.41 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | -4.0 percent change from baseline | Standard Deviation 29.21 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | -42.5 percent change from baseline | Standard Deviation 18.66 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | -67.5 percent change from baseline | Standard Deviation 2.19 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | -5.9 percent change from baseline | Standard Deviation 30.05 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | -9.3 percent change from baseline | Standard Deviation 27.89 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 39.6 percent change from baseline | Standard Deviation 45.07 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 3.6 percent change from baseline | Standard Deviation 27.54 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 0.7 percent change from baseline | Standard Deviation 25.53 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | -6.1 percent change from baseline | Standard Deviation 18.12 |
Secondary
Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits
Percent change from Baseline to End of study summary statistics of exhaled carbon monoxide for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 17.00 percent change from baseline | Standard Deviation 4.243 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 21.32 percent change from baseline | Standard Deviation 10.133 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 29.64 percent change from baseline | Standard Deviation 12.118 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 22.50 percent change from baseline | Standard Deviation 9.562 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 18.50 percent change from baseline | Standard Deviation 16.263 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 20.63 percent change from baseline | Standard Deviation 9.855 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 22.24 percent change from baseline | Standard Deviation 10.491 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 20.96 percent change from baseline | Standard Deviation 11.126 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 20.59 percent change from baseline | Standard Deviation 9.109 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 20.42 percent change from baseline | Standard Deviation 10.046 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 11.50 percent change from baseline | Standard Deviation 10.607 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 20.15 percent change from baseline | Standard Deviation 10.41 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 13.00 percent change from baseline | Standard Deviation 8.485 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 21.50 percent change from baseline | Standard Deviation 9.957 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 25.91 percent change from baseline | Standard Deviation 8.86 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 4.00 percent change from baseline | Standard Deviation 2.828 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 21.13 percent change from baseline | Standard Deviation 10.091 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 9.88 percent change from baseline | Standard Deviation 6.081 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 18.50 percent change from baseline | Standard Deviation 2.121 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 19.65 percent change from baseline | Standard Deviation 8.939 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 20.21 percent change from baseline | Standard Deviation 9.537 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 19.08 percent change from baseline | Standard Deviation 8.707 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 6.0 percent change from baseline | Standard Deviation 47.63 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | -7.0 percent change from baseline | Standard Deviation 32.63 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 6.6 percent change from baseline | Standard Deviation 45.21 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | -49.2 percent change from baseline | Standard Deviation 27.25 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | -77.9 percent change from baseline | Standard Deviation 11.11 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | -18.3 percent change from baseline | Standard Deviation 25.93 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | -3.1 percent change from baseline | Standard Deviation 47 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 165.1 percent change from baseline | Standard Deviation 226.09 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6.8 percent change from baseline | Standard Deviation 58.17 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 9.0 percent change from baseline | Standard Deviation 66.04 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | -1.4 percent change from baseline | Standard Deviation 40.74 |
Secondary
Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits
Percent change from Baseline to End of study summary statistics of urinary nicotine equivalents (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide). Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 8.19 percent change from baseline | Standard Deviation 1.87 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 15.00 percent change from baseline | Standard Deviation 9.726 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 18.24 percent change from baseline | Standard Deviation 14.941 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 8.75 percent change from baseline | Standard Deviation 4.809 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 9.09 percent change from baseline | Standard Deviation 1.956 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 11.51 percent change from baseline | Standard Deviation 6.995 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 14.32 percent change from baseline | Standard Deviation 9.996 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 14.77 percent change from baseline | Standard Deviation 10.432 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 13.70 percent change from baseline | Standard Deviation 7.87 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 14.06 percent change from baseline | Standard Deviation 8.973 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 8.14 percent change from baseline | — |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 16.60 percent change from baseline | Standard Deviation 13.108 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 8.81 percent change from baseline | Standard Deviation 0.629 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 10.23 percent change from baseline | Standard Deviation 3.053 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 24.84 percent change from baseline | Standard Deviation 14.892 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 7.41 percent change from baseline | — |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 16.07 percent change from baseline | Standard Deviation 11.551 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 16.62 percent change from baseline | Standard Deviation 22.808 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 13.62 percent change from baseline | Standard Deviation 1.6 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 17.13 percent change from baseline | Standard Deviation 11.092 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 16.55 percent change from baseline | Standard Deviation 6.791 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 18.07 percent change from baseline | Standard Deviation 14.909 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 19.0 percent change from baseline | Standard Deviation 61.98 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 62.5 percent change from baseline | Standard Deviation 69.5 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 40.0 percent change from baseline | Standard Deviation 55.51 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 15.1 percent change from baseline | Standard Deviation 93.59 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | -22.1 percent change from baseline | — |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | -0.1 percent change from baseline | Standard Deviation 28.42 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 25.2 percent change from baseline | Standard Deviation 65.08 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 81.1 percent change from baseline | — |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 41.1 percent change from baseline | Standard Deviation 72.4 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 35.5 percent change from baseline | Standard Deviation 60.54 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 27.6 percent change from baseline | Standard Deviation 46.51 |
Secondary
Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits
Percent change from Baseline to End of study summary statistics of urinary S-phenyl mercapturic acid \[S-PMA\] (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 5510.19 percent change from baseline | Standard Deviation 123.439 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 6495.06 percent change from baseline | Standard Deviation 5936.803 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5731.61 percent change from baseline | Standard Deviation 5064.881 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 4216.93 percent change from baseline | Standard Deviation 2660.723 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 2693.13 percent change from baseline | Standard Deviation 1334.197 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 5352.66 percent change from baseline | Standard Deviation 8413.472 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5991.56 percent change from baseline | Standard Deviation 5741.49 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5356.63 percent change from baseline | Standard Deviation 5359.524 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 4934.00 percent change from baseline | Standard Deviation 4812.35 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5195.78 percent change from baseline | Standard Deviation 4999.201 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 6930.38 percent change from baseline | Standard Deviation 5483.666 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 7098.86 percent change from baseline | Standard Deviation 7113.465 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 2896.76 percent change from baseline | Standard Deviation 1518.588 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 4352.99 percent change from baseline | Standard Deviation 3873.342 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 8389.80 percent change from baseline | Standard Deviation 6625.523 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 440.59 percent change from baseline | Standard Deviation 225.383 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 7335.57 percent change from baseline | Standard Deviation 7068.643 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 9795.94 percent change from baseline | Standard Deviation 12602.08 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 8688.22 percent change from baseline | Standard Deviation 3272.243 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 6502.50 percent change from baseline | Standard Deviation 5540.461 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6358.61 percent change from baseline | Standard Deviation 5253.083 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 6481.35 percent change from baseline | Standard Deviation 6132.009 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 19.9 percent change from baseline | Standard Deviation 76.46 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 50.0 percent change from baseline | Standard Deviation 58.51 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 16.1 percent change from baseline | Standard Deviation 61.36 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 30.3 percent change from baseline | Standard Deviation 123.78 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | -92.0 percent change from baseline | Standard Deviation 3.91 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 6.7 percent change from baseline | Standard Deviation 3.53 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 20.9 percent change from baseline | Standard Deviation 76.27 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 55.3 percent change from baseline | Standard Deviation 75.66 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 46.5 percent change from baseline | Standard Deviation 76.26 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 39.1 percent change from baseline | Standard Deviation 70.93 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 29.4 percent change from baseline | Standard Deviation 66.18 |
Secondary
Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits
Percent change from Baseline to End of study summary statistics of urinary total NNAL (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 303.45 percent change from baseline | Standard Deviation 252.531 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 551.02 percent change from baseline | Standard Deviation 318.27 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 443.02 percent change from baseline | Standard Deviation 343.687 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 535.46 percent change from baseline | Standard Deviation 393.698 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 507.43 percent change from baseline | Standard Deviation 365.172 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 158.65 percent change from baseline | Standard Deviation 2.244 |
| Test (ad Libitum VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 456.39 percent change from baseline | Standard Deviation 275.603 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 473.50 percent change from baseline | Standard Deviation 347.581 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 487.20 percent change from baseline | Standard Deviation 378.047 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 440.36 percent change from baseline | Standard Deviation 261.806 |
| Control (no VBM-FG2) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 789.56 percent change from baseline | Standard Deviation 1039.9 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 28.69 percent change from baseline | Standard Deviation 17.194 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 721.93 percent change from baseline | Standard Deviation 327.377 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | 268.14 percent change from baseline | Standard Deviation 172.499 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 389.46 percent change from baseline | Standard Deviation 170.153 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 586.29 percent change from baseline | Standard Deviation 525.084 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 614.61 percent change from baseline | Standard Deviation 517.499 |
| Test (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 592.73 percent change from baseline | Standard Deviation 932.562 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | 592.51 percent change from baseline | Standard Deviation 741.128 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 563.30 percent change from baseline | Standard Deviation 376.309 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 538.09 percent change from baseline | Standard Deviation 287.478 |
| Control (Visit 5) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 590.28 percent change from baseline | Standard Deviation 451.453 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 7.3 percent change from baseline | Standard Deviation 80.69 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 43.2 percent change from baseline | Standard Deviation 49.11 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | -0.3 percent change from baseline | Standard Deviation 29.55 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 17.6 percent change from baseline | Standard Deviation 63.88 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | -82.0 percent change from baseline | Standard Deviation 10.58 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Missing | -1.0 percent change from baseline | Standard Deviation 25.53 |
| Test (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 15.4 percent change from baseline | Standard Deviation 62.42 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | No Change | -0.3 percent change from baseline | Standard Deviation 37.46 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Increase | 31.7 percent change from baseline | Standard Deviation 66.12 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Overall | 28.4 percent change from baseline | Standard Deviation 57.66 |
| Control (Visit 6) | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 26.9 percent change from baseline | Standard Deviation 48.8 |
Secondary
Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits
Summary statistics of blood carboxyhemoglobin in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented.
Time frame: Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Missing | 3.5 percent saturation of carboxyhemoglobin | Standard Deviation 1.63 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | No Change | 4.7 percent saturation of carboxyhemoglobin | Standard Deviation 1.57 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 4.5 percent saturation of carboxyhemoglobin | Standard Deviation 0.14 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6.5 percent saturation of carboxyhemoglobin | Standard Deviation 2.61 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5.5 percent saturation of carboxyhemoglobin | Standard Deviation 2.01 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.4 percent saturation of carboxyhemoglobin | Standard Deviation 2.11 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 5.0 percent saturation of carboxyhemoglobin | Standard Deviation 2.5 |
| Control (no VBM-FG2) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | No Change | 3.9 percent saturation of carboxyhemoglobin | Standard Deviation 0.14 |
| Control (no VBM-FG2) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5.0 percent saturation of carboxyhemoglobin | Standard Deviation 2.35 |
| Control (no VBM-FG2) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.3 percent saturation of carboxyhemoglobin | Standard Deviation 2.18 |
| Control (no VBM-FG2) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5.5 percent saturation of carboxyhemoglobin | Standard Deviation 2.1 |
| Test (Visit 5) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5.4 percent saturation of carboxyhemoglobin | Standard Deviation 1.92 |
| Test (Visit 5) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6.6 percent saturation of carboxyhemoglobin | Standard Deviation 2.15 |
| Test (Visit 5) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.5 percent saturation of carboxyhemoglobin | Standard Deviation 1.99 |
| Test (Visit 5) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Missing | 4.3 percent saturation of carboxyhemoglobin | Standard Deviation 2.33 |
| Test (Visit 5) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 4.5 percent saturation of carboxyhemoglobin | Standard Deviation 0.35 |
| Test (Visit 5) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | No Change | 5.7 percent saturation of carboxyhemoglobin | Standard Deviation 2.15 |
| Test (Visit 5) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 5.4 percent saturation of carboxyhemoglobin | Standard Deviation 2.16 |
| Control (Visit 5) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5.3 percent saturation of carboxyhemoglobin | Standard Deviation 1.63 |
| Control (Visit 5) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.1 percent saturation of carboxyhemoglobin | Standard Deviation 1.9 |
| Control (Visit 5) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5.0 percent saturation of carboxyhemoglobin | Standard Deviation 2.18 |
| Control (Visit 5) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | No Change | 3.7 percent saturation of carboxyhemoglobin | Standard Deviation 2.19 |
| Test (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | No Change | 5.2 percent saturation of carboxyhemoglobin | Standard Deviation 1.73 |
| Test (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6.2 percent saturation of carboxyhemoglobin | Standard Deviation 2.15 |
| Test (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5.2 percent saturation of carboxyhemoglobin | Standard Deviation 2.05 |
| Test (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 4.7 percent saturation of carboxyhemoglobin | Standard Deviation 2.03 |
| Test (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 2.0 percent saturation of carboxyhemoglobin | Standard Deviation 0.64 |
| Test (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Missing | 2.2 percent saturation of carboxyhemoglobin | Standard Deviation 0.14 |
| Test (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.1 percent saturation of carboxyhemoglobin | Standard Deviation 2.1 |
| Control (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 4.8 percent saturation of carboxyhemoglobin | Standard Deviation 2.15 |
| Control (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | No Change | 3.3 percent saturation of carboxyhemoglobin | Standard Deviation 0.14 |
| Control (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.1 percent saturation of carboxyhemoglobin | Standard Deviation 1.91 |
| Control (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5.5 percent saturation of carboxyhemoglobin | Standard Deviation 1.65 |
| Test (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | No Change | 5.2 percent saturation of carboxyhemoglobin | Standard Deviation 1.76 |
| Test (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6.8 percent saturation of carboxyhemoglobin | Standard Deviation 2.46 |
| Test (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Missing | 3.3 percent saturation of carboxyhemoglobin | Standard Deviation 1.98 |
| Test (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 4.4 percent saturation of carboxyhemoglobin | Standard Deviation 1.98 |
| Test (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 1.2 percent saturation of carboxyhemoglobin | Standard Deviation 0.21 |
| Test (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.3 percent saturation of carboxyhemoglobin | Standard Deviation 2.32 |
| Test (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5.4 percent saturation of carboxyhemoglobin | Standard Deviation 2.24 |
| Control (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.5 percent saturation of carboxyhemoglobin | Standard Deviation 2.23 |
| Control (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5.0 percent saturation of carboxyhemoglobin | Standard Deviation 2.08 |
| Control (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | No Change | 3.2 percent saturation of carboxyhemoglobin | Standard Deviation 0.07 |
| Control (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6.1 percent saturation of carboxyhemoglobin | Standard Deviation 2.26 |
| Test (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 3.7 percent saturation of carboxyhemoglobin | Standard Deviation 1.9 |
| Test (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Missing | 4.1 percent saturation of carboxyhemoglobin | Standard Deviation 1.91 |
| Test (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 1.2 percent saturation of carboxyhemoglobin | Standard Deviation 0 |
| Test (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.5 percent saturation of carboxyhemoglobin | Standard Deviation 2.33 |
| Test (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5.8 percent saturation of carboxyhemoglobin | Standard Deviation 2.28 |
| Test (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | No Change | 4.9 percent saturation of carboxyhemoglobin | Standard Deviation 1.42 |
| Test (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6.6 percent saturation of carboxyhemoglobin | Standard Deviation 2.15 |
| Control (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.5 percent saturation of carboxyhemoglobin | Standard Deviation 1.98 |
| Control (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5.8 percent saturation of carboxyhemoglobin | Standard Deviation 2.07 |
| Control (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5.1 percent saturation of carboxyhemoglobin | Standard Deviation 1.82 |
| Control (Visit 6) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | No Change | 5.6 percent saturation of carboxyhemoglobin | Standard Deviation 3.11 |
| Test (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Overall | 4.9 percent saturation of carboxyhemoglobin | Standard Deviation 2.07 |
| Test (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 1.5 percent saturation of carboxyhemoglobin | Standard Deviation 0.21 |
| Test (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 3.2 percent saturation of carboxyhemoglobin | Standard Deviation 1.87 |
| Test (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | No Change | 5.0 percent saturation of carboxyhemoglobin | Standard Deviation 1.28 |
| Test (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Missing | 3.7 percent saturation of carboxyhemoglobin | Standard Deviation 0.92 |
| Test (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6.0 percent saturation of carboxyhemoglobin | Standard Deviation 1.8 |
| Test (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5.1 percent saturation of carboxyhemoglobin | Standard Deviation 2.07 |
| Control (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 4.6 percent saturation of carboxyhemoglobin | Standard Deviation 1.85 |
| Control (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5.0 percent saturation of carboxyhemoglobin | Standard Deviation 1.82 |
| Control (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | No Change | 4.6 percent saturation of carboxyhemoglobin | Standard Deviation 1.41 |
| Control (End of Study) | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5.4 percent saturation of carboxyhemoglobin | Standard Deviation 1.79 |
Secondary
Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)
Summary statistics of change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Visit 4 | -0.42 percent saturation of carboxyhemoglobin | Standard Deviation 1.449 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Visit 5 | -0.24 percent saturation of carboxyhemoglobin | Standard Deviation 1.418 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Visit 6 | -0.02 percent saturation of carboxyhemoglobin | Standard Deviation 1.547 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | End of Study/Early Termination | -0.61 percent saturation of carboxyhemoglobin | Standard Deviation 1.387 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | End of Study/Early Termination | -0.10 percent saturation of carboxyhemoglobin | Standard Deviation 1.118 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Visit 4 | 0.03 percent saturation of carboxyhemoglobin | Standard Deviation 1.46 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Visit 6 | 0.39 percent saturation of carboxyhemoglobin | Standard Deviation 1.299 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Visit 5 | 0.39 percent saturation of carboxyhemoglobin | Standard Deviation 1.374 |
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobinp-value: 0.024195% CI: [-0.946, -0.0674]t-test, 2 sided
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobinp-value: 0.129295% CI: [-0.843, 0.108]t-test, 2 sided
Secondary
Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population)
Summary statistics of change from Baseline for exhaled carbon monoxide (ppm) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population) | Visit 4 | -1.4 ppm | Standard Deviation 9.41 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population) | Visit 5 | -1.9 ppm | Standard Deviation 7.48 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population) | Visit 6 | -0.8 ppm | Standard Deviation 9.3 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population) | End of Study/Early Termination | -2.3 ppm | Standard Deviation 9.17 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population) | End of Study/Early Termination | -0.8 ppm | Standard Deviation 6.9 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population) | Visit 4 | -0.2 ppm | Standard Deviation 7.84 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population) | Visit 6 | 0.6 ppm | Standard Deviation 7.89 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population) | Visit 5 | 0.7 ppm | Standard Deviation 8.37 |
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxidep-value: 0.296195% CI: [-4.36, 1.34]t-test, 2 sided
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxidep-value: 0.501595% CI: [-4.12, 2.03]t-test, 2 sided
Secondary
Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population)
Summary statistics of change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (mg/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population) | Visit 4 | -0.6 mg/g | Standard Deviation 5.28 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population) | Visit 5 | 1.9 mg/g | Standard Deviation 8.46 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population) | Visit 6 | 1.1 mg/g | Standard Deviation 8.03 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population) | End of Study/Early Termination | 2.6 mg/g | Standard Deviation 9.75 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population) | End of Study/Early Termination | 3.6 mg/g | Standard Deviation 6.89 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population) | Visit 4 | 0.6 mg/g | Standard Deviation 6.45 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population) | Visit 6 | 4.3 mg/g | Standard Deviation 9.47 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population) | Visit 5 | 2.5 mg/g | Standard Deviation 6.48 |
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalentsp-value: 0.490395% CI: [-4.35, 2.1]t-test, 2 sided
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalentsp-value: 0.425195% CI: [-4.88, 2.07]t-test, 2 sided
Secondary
Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population)
Summary statistics of change from Baseline for urinary S-phenyl mercapturic acid \[S-PMA\] (ng/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population) | Visit 6 | 1102.42 ng/g | Standard Deviation 4045.946 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population) | Visit 4 | 506.33 ng/g | Standard Deviation 3150.049 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population) | End of Study/Early Termination | 903.49 ng/g | Standard Deviation 4985.072 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population) | Visit 5 | 1129.88 ng/g | Standard Deviation 4867.996 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population) | End of Study/Early Termination | 1160.48 ng/g | Standard Deviation 2798.644 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population) | Visit 4 | 242.66 ng/g | Standard Deviation 2846.817 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population) | Visit 6 | 1637.29 ng/g | Standard Deviation 4348.05 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population) | Visit 5 | 809.04 ng/g | Standard Deviation 3649.614 |
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMAp-value: 0.72495% CI: [-1773, 1235]t-test, 2 sided
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMAp-value: 0.950895% CI: [-1566, 1667]t-test, 2 sided
Secondary
Summary Statistics of Change From Baseline for Total Score of Fagerstrom Test for Cigarette Dependence (Per-Protocol Population)
Summary statistics of change from Baseline for Total Score of Fagerstrom Test for Cigarette Dependence at the end of study/early termination are presented. The Fagerstrom Test for Nicotine Dependence consists of Yes/No and multiple-choice questions where each response is assigned a value from 0 to 1 (for yes/no questions) or 0 to 3 (for multiple-choice questions). Values are summed to yield a total score with a minimum score of 0 points and a maximum score of 10 points. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. Baseline = Visit 3 (Day 8) value Population: Per-Protocol
Time frame: Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Total Score of Fagerstrom Test for Cigarette Dependence (Per-Protocol Population) | -0.4 scores on a scale | Standard Deviation 1.66 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Total Score of Fagerstrom Test for Cigarette Dependence (Per-Protocol Population) | 0.0 scores on a scale | Standard Deviation 0.82 |
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependencep-value: 0.091995% CI: [-0.884, 0.0673]t-test, 2 sided
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependencep-value: 0.097595% CI: [-0.886, 0.0751]t-test, 2 sided
Comparison: Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependencep-value: 0.064395% CI: [-17.1, 0.499]t-test, 2 sided
Comparison: Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependencep-value: 0.051795% CI: [-17.7, 0.0661]t-test, 2 sided
Secondary
Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population)
Summary statistics of change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \[NNAL\] (ng/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population) | Visit 4 | 14.99 ng/g | Standard Deviation 212.505 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population) | Visit 5 | 70.90 ng/g | Standard Deviation 436.326 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population) | Visit 6 | 66.23 ng/g | Standard Deviation 303.806 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population) | End of Study/Early Termination | 81.33 ng/g | Standard Deviation 345.11 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population) | End of Study/Early Termination | 86.53 ng/g | Standard Deviation 209.749 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population) | Visit 4 | 9.47 ng/g | Standard Deviation 207.308 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population) | Visit 6 | 117.69 ng/g | Standard Deviation 289.763 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population) | Visit 5 | 76.50 ng/g | Standard Deviation 310.423 |
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study in urinary total NNALp-value: 0.943395% CI: [-107, 99.4]t-test, 2 sided
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in urinary total NNALp-value: 0.826495% CI: [-122, 97.5]t-test, 2 sided
Secondary
Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population)
Summary statistics of change from Baseline in number or products used day in each study visit are presented. Values for visit are the average of daily values for the previous week Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population) | Visit 4 | -2.7 cigarettes per day | Standard Deviation 3.28 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population) | Visit 5 | -3.1 cigarettes per day | Standard Deviation 4.34 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population) | Visit 6 | -2.9 cigarettes per day | Standard Deviation 4.41 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population) | End of Study/Early Termination | -3.5 cigarettes per day | Standard Deviation 4.78 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population) | End of Study/Early Termination | 0.4 cigarettes per day | Standard Deviation 2.76 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population) | Visit 4 | 0.5 cigarettes per day | Standard Deviation 1.96 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population) | Visit 6 | 0.3 cigarettes per day | Standard Deviation 2.78 |
| Control (no VBM-FG2) | Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population) | Visit 5 | 0.3 cigarettes per day | Standard Deviation 2.37 |
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per dayp-value: <0.000195% CI: [-5.25, -2.47]t-test, 2 sided
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per dayp-value: <0.000195% CI: [-5.14, -2.34]t-test, 2 sided
Secondary
Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8
Summary Statistics of Cigarettes Smoked per Day collected by IVRS Data method on Days 1 to 8 for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented.
Time frame: Daily during Baseline Period (Day 1 to Day 8)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 19.1 cigarettes per day | Standard Deviation 5.92 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 18.2 cigarettes per day | Standard Deviation 6.26 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 16.5 cigarettes per day | Standard Deviation 3.67 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 17.4 cigarettes per day | Standard Deviation 8.43 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Missing | 15.0 cigarettes per day | Standard Deviation 7.07 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | 100% Reduction | 8.5 cigarettes per day | Standard Deviation 4.95 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | 50% to < 100% Reduction | 18.4 cigarettes per day | Standard Deviation 8.22 |
| Control (no VBM-FG2) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 19.1 cigarettes per day | Standard Deviation 8.04 |
| Control (no VBM-FG2) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 20.0 cigarettes per day | Standard Deviation 0 |
| Control (no VBM-FG2) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 18.4 cigarettes per day | Standard Deviation 7.49 |
| Control (no VBM-FG2) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 17.4 cigarettes per day | Standard Deviation 7.12 |
| Test (Visit 5) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 17.3 cigarettes per day | Standard Deviation 5.72 |
| Test (Visit 5) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Missing | 15.0 cigarettes per day | Standard Deviation 7.07 |
| Test (Visit 5) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 15.4 cigarettes per day | Standard Deviation 4.42 |
| Test (Visit 5) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | 100% Reduction | 11.5 cigarettes per day | Standard Deviation 4.95 |
| Test (Visit 5) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 17.9 cigarettes per day | Standard Deviation 5.5 |
| Test (Visit 5) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | 50% to < 100% Reduction | 16.2 cigarettes per day | Standard Deviation 5.85 |
| Test (Visit 5) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 18.7 cigarettes per day | Standard Deviation 8.3 |
| Control (Visit 5) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 17.4 cigarettes per day | Standard Deviation 8.39 |
| Control (Visit 5) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 20.0 cigarettes per day | Standard Deviation 0 |
| Control (Visit 5) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 19.1 cigarettes per day | Standard Deviation 6.48 |
| Control (Visit 5) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 18.2 cigarettes per day | Standard Deviation 7.41 |
| Test (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 17.4 cigarettes per day | Standard Deviation 8.4 |
| Test (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 17.2 cigarettes per day | Standard Deviation 5.68 |
| Test (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | 50% to < 100% Reduction | 19.1 cigarettes per day | Standard Deviation 6.28 |
| Test (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Missing | 15.5 cigarettes per day | Standard Deviation 6.36 |
| Test (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | 100% Reduction | 8.5 cigarettes per day | Standard Deviation 2.12 |
| Test (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 17.3 cigarettes per day | Standard Deviation 5.06 |
| Test (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 17.0 cigarettes per day | Standard Deviation 5.13 |
| Control (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 20.0 cigarettes per day | Standard Deviation 0 |
| Control (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 20.2 cigarettes per day | Standard Deviation 7.46 |
| Control (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 20.00 cigarettes per day | Standard Deviation 8.66 |
| Control (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 20.6 cigarettes per day | Standard Deviation 6.45 |
| Test (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Missing | 16.0 cigarettes per day | Standard Deviation 5.66 |
| Test (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 17.0 cigarettes per day | Standard Deviation 5.34 |
| Test (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 17.6 cigarettes per day | Standard Deviation 8.28 |
| Test (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 18.8 cigarettes per day | Standard Deviation 5.42 |
| Test (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | 50% to < 100% Reduction | 17.4 cigarettes per day | Standard Deviation 5.66 |
| Test (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | 100% Reduction | 10.0 cigarettes per day | — |
| Test (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 18.1 cigarettes per day | Standard Deviation 5.74 |
| Control (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 20.0 cigarettes per day | — |
| Control (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 21.2 cigarettes per day | Standard Deviation 7.06 |
| Control (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 20.7 cigarettes per day | Standard Deviation 7.79 |
| Control (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 20.3 cigarettes per day | Standard Deviation 8.49 |
| Test (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 18.4 cigarettes per day | Standard Deviation 8.52 |
| Test (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | 50% to < 100% Reduction | 18.6 cigarettes per day | Standard Deviation 5.62 |
| Test (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 17.8 cigarettes per day | Standard Deviation 5.64 |
| Test (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Missing | 17.0 cigarettes per day | Standard Deviation 7.07 |
| Test (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 15.8 cigarettes per day | Standard Deviation 5.31 |
| Test (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 17.6 cigarettes per day | Standard Deviation 5.83 |
| Control (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 20.0 cigarettes per day | — |
| Control (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 20.8 cigarettes per day | Standard Deviation 8.3 |
| Control (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 19.4 cigarettes per day | Standard Deviation 9.63 |
| Control (Visit 6) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 20.0 cigarettes per day | Standard Deviation 8.87 |
| Test (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 17.1 cigarettes per day | Standard Deviation 8.54 |
| Test (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 17.9 cigarettes per day | Standard Deviation 5.77 |
| Test (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 15.8 cigarettes per day | Standard Deviation 7.91 |
| Test (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | 100% Reduction | 15.0 cigarettes per day | Standard Deviation 0 |
| Test (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Missing | 17.0 cigarettes per day | Standard Deviation 7.07 |
| Test (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 17.4 cigarettes per day | Standard Deviation 6.37 |
| Test (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | 50% to < 100% Reduction | 18.3 cigarettes per day | Standard Deviation 8.88 |
| Control (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 20.0 cigarettes per day | Standard Deviation 0 |
| Control (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 20.0 cigarettes per day | Standard Deviation 7.96 |
| Control (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 20.7 cigarettes per day | Standard Deviation 9.82 |
| Control (End of Study) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 19.1 cigarettes per day | Standard Deviation 5.77 |
| Test (Day 7) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 17.5 cigarettes per day | Standard Deviation 8.33 |
| Test (Day 7) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 18.9 cigarettes per day | Standard Deviation 5.39 |
| Test (Day 7) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 15.4 cigarettes per day | Standard Deviation 9.06 |
| Test (Day 7) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | 100% Reduction | 11.5 cigarettes per day | Standard Deviation 3.54 |
| Test (Day 7) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Missing | 21.0 cigarettes per day | Standard Deviation 12.73 |
| Test (Day 7) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 18.0 cigarettes per day | Standard Deviation 6.93 |
| Test (Day 7) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | 50% to < 100% Reduction | 17.4 cigarettes per day | Standard Deviation 10.44 |
| Control (Day 7) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 18.8 cigarettes per day | Standard Deviation 6.74 |
| Control (Day 7) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 18.4 cigarettes per day | Standard Deviation 8.75 |
| Control (Day 7) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 20.0 cigarettes per day | Standard Deviation 0 |
| Control (Day 7) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 18.7 cigarettes per day | Standard Deviation 7.48 |
| Test (Day 8) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 17.5 cigarettes per day | Standard Deviation 7.67 |
| Test (Day 8) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 17.3 cigarettes per day | Standard Deviation 8.48 |
| Test (Day 8) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | 100% Reduction | 11.0 cigarettes per day | Standard Deviation 5.66 |
| Test (Day 8) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Missing | 17.5 cigarettes per day | Standard Deviation 10.61 |
| Test (Day 8) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 18.2 cigarettes per day | Standard Deviation 6.01 |
| Test (Day 8) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | 50% to < 100% Reduction | 19.0 cigarettes per day | Standard Deviation 5.86 |
| Test (Day 8) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 18.6 cigarettes per day | Standard Deviation 5.21 |
| Control (Day 8) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Increase | 19.3 cigarettes per day | Standard Deviation 8.58 |
| Control (Day 8) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | <50% Reduction | 19.0 cigarettes per day | Standard Deviation 6.87 |
| Control (Day 8) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Overall | 19.2 cigarettes per day | Standard Deviation 7.63 |
| Control (Day 8) | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | No Change | 20.0 cigarettes per day | Standard Deviation 0 |
Secondary
Summary Statistics of Cigarettes Smoked Per Day on Visits 2 (Day 1) and 3 (Day 8)
Summary statistics of average cigarettes smoked per day \[CPD\] over previous 7 days collected from Cigarette Use questionnaire on Visit 2 (Day 1) and Visit 3 (Day 8) are presented.
Time frame: Day 1 (Visit 2) and Day 8 (Visit 3)
Population: Per-protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Cigarettes Smoked Per Day on Visits 2 (Day 1) and 3 (Day 8) | 17.7 cigarettes per day | Standard Deviation 6.04 |
| Control (no VBM-FG2) | Summary Statistics of Cigarettes Smoked Per Day on Visits 2 (Day 1) and 3 (Day 8) | 19.8 cigarettes per day | Standard Deviation 7.64 |
| Test (Visit 5) | Summary Statistics of Cigarettes Smoked Per Day on Visits 2 (Day 1) and 3 (Day 8) | 17.6 cigarettes per day | Standard Deviation 5.36 |
| Control (Visit 5) | Summary Statistics of Cigarettes Smoked Per Day on Visits 2 (Day 1) and 3 (Day 8) | 20.0 cigarettes per day | Standard Deviation 7.43 |
Secondary
Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits
Summary Statistics of exhaled carbon monoxide in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented.
Time frame: Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Missing | 20.5 ppm | Standard Deviation 14.85 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | No Change | 17.3 ppm | Standard Deviation 10.77 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 20.0 ppm | Standard Deviation 5.66 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Increase | 28.3 ppm | Standard Deviation 11.13 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 22.2 ppm | Standard Deviation 9.21 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Overall | 22.1 ppm | Standard Deviation 10.05 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 19.3 ppm | Standard Deviation 12.14 |
| Control (no VBM-FG2) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | No Change | 15.5 ppm | Standard Deviation 3.54 |
| Control (no VBM-FG2) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 22.3 ppm | Standard Deviation 10.87 |
| Control (no VBM-FG2) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Overall | 21.4 ppm | Standard Deviation 10.03 |
| Control (no VBM-FG2) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Increase | 21.0 ppm | Standard Deviation 9.65 |
| Test (Visit 5) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 21.6 ppm | Standard Deviation 10.01 |
| Test (Visit 5) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Increase | 29.6 ppm | Standard Deviation 12.12 |
| Test (Visit 5) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Overall | 22.4 ppm | Standard Deviation 10.4 |
| Test (Visit 5) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Missing | 18.5 ppm | Standard Deviation 16.26 |
| Test (Visit 5) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 17.0 ppm | Standard Deviation 4.24 |
| Test (Visit 5) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | No Change | 22.5 ppm | Standard Deviation 9.56 |
| Test (Visit 5) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 20.6 ppm | Standard Deviation 9.86 |
| Control (Visit 5) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Increase | 20.6 ppm | Standard Deviation 9.11 |
| Control (Visit 5) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Overall | 20.4 ppm | Standard Deviation 10.05 |
| Control (Visit 5) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 21.0 ppm | Standard Deviation 11.13 |
| Control (Visit 5) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | No Change | 11.5 ppm | Standard Deviation 10.61 |
| Test (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | No Change | 21.6 ppm | Standard Deviation 8.88 |
| Test (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Increase | 28.5 ppm | Standard Deviation 15.29 |
| Test (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 20.9 ppm | Standard Deviation 11.16 |
| Test (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 18.0 ppm | Standard Deviation 8.83 |
| Test (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 4.5 ppm | Standard Deviation 0.71 |
| Test (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Missing | 10.5 ppm | Standard Deviation 2.12 |
| Test (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Overall | 21.0 ppm | Standard Deviation 11.68 |
| Control (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 19.4 ppm | Standard Deviation 10.89 |
| Control (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | No Change | 12.0 ppm | Standard Deviation 4.24 |
| Control (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Overall | 20.2 ppm | Standard Deviation 9.62 |
| Control (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Increase | 21.4 ppm | Standard Deviation 8.57 |
| Test (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | No Change | 22.4 ppm | Standard Deviation 10.88 |
| Test (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Increase | 28.1 ppm | Standard Deviation 13.6 |
| Test (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Missing | 9.5 ppm | Standard Deviation 6.36 |
| Test (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 15.5 ppm | Standard Deviation 8.38 |
| Test (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 2.5 ppm | Standard Deviation 0.71 |
| Test (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Overall | 20.5 ppm | Standard Deviation 11.18 |
| Test (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 20.5 ppm | Standard Deviation 10.25 |
| Control (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Overall | 21.1 ppm | Standard Deviation 11.81 |
| Control (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 19.9 ppm | Standard Deviation 9.98 |
| Control (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | No Change | 11.5 ppm | Standard Deviation 2.12 |
| Control (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Increase | 22.7 ppm | Standard Deviation 13.28 |
| Test (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 12.1 ppm | Standard Deviation 8.54 |
| Test (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Missing | 15.5 ppm | Standard Deviation 12.02 |
| Test (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 5.5 ppm | Standard Deviation 2.12 |
| Test (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Overall | 21.7 ppm | Standard Deviation 11.71 |
| Test (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 23.0 ppm | Standard Deviation 11.32 |
| Test (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | No Change | 19.3 ppm | Standard Deviation 9.82 |
| Test (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Increase | 27.8 ppm | Standard Deviation 12.32 |
| Control (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Overall | 21.0 ppm | Standard Deviation 9.77 |
| Control (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Increase | 21.8 ppm | Standard Deviation 10.44 |
| Control (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 20.4 ppm | Standard Deviation 9.24 |
| Control (Visit 6) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | No Change | 18.0 ppm | Standard Deviation 9.9 |
| Test (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Overall | 20.1 ppm | Standard Deviation 10.41 |
| Test (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 4.0 ppm | Standard Deviation 2.83 |
| Test (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 9.9 ppm | Standard Deviation 6.08 |
| Test (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | No Change | 21.5 ppm | Standard Deviation 9.96 |
| Test (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Missing | 13.0 ppm | Standard Deviation 8.49 |
| Test (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Increase | 25.9 ppm | Standard Deviation 8.86 |
| Test (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 21.1 ppm | Standard Deviation 10.09 |
| Control (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 19.1 ppm | Standard Deviation 8.71 |
| Control (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Overall | 19.7 ppm | Standard Deviation 8.94 |
| Control (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | No Change | 18.5 ppm | Standard Deviation 2.12 |
| Control (End of Study) | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Increase | 20.2 ppm | Standard Deviation 9.54 |
Secondary
Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)
Summary statistics of percent change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Visit 4 | -6.3 percent change from baseline | Standard Deviation 27.48 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Visit 5 | -4.0 percent change from baseline | Standard Deviation 26.17 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Visit 6 | 1.4 percent change from baseline | Standard Deviation 28.26 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | End of Study/Early Termination | -9.3 percent change from baseline | Standard Deviation 27.89 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | End of Study/Early Termination | 0.7 percent change from baseline | Standard Deviation 25.53 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Visit 4 | 5.3 percent change from baseline | Standard Deviation 35.59 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Visit 6 | 11.3 percent change from baseline | Standard Deviation 29.44 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Visit 5 | 9.8 percent change from baseline | Standard Deviation 27.21 |
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobinp-value: 0.033395% CI: [-19.2, -0.803]t-test, 2 sided
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobinp-value: 0.176795% CI: [-16.6, 3.08]t-test, 2 sided
Secondary
Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population)
Summary statistics of percent change from Baseline of number of products used per day in each study visit are presented. CPD was tracked using an interactive voice response system (IVRS). During the Baseline Period (Days 1 to 8), subjects reported CPD daily through an IVRS each day between 16:00 and 19:00. Test and Control subjects continued daily tobacco use tracking via an IVRS and return to the study site once a week during the 4 week Product Use Period on Days 15, 22, 29, and 36. Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing the calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS procedure.
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population) | Visit 4 | -15.0 percent change from baseline | Standard Deviation 19.3 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population) | Visit 5 | -16.5 percent change from baseline | Standard Deviation 26.21 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population) | Visit 6 | -16.3 percent change from baseline | Standard Deviation 24.78 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population) | End of Study/Early Termination | -19.2 percent change from baseline | Standard Deviation 27.03 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population) | End of Study/Early Termination | 3.2 percent change from baseline | Standard Deviation 17.28 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population) | Visit 4 | 3.1 percent change from baseline | Standard Deviation 10.85 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population) | Visit 6 | 2.9 percent change from baseline | Standard Deviation 18.01 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population) | Visit 5 | 2.9 percent change from baseline | Standard Deviation 15.18 |
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per dayp-value: <0.000195% CI: [-30.5, -14.5]t-test, 2 sided
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per dayp-value: <0.000195% CI: [-30.4, -14.1]t-test, 2 sided
Secondary
Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population)
Summary statistics of percent change from Baseline for exhaled carbon monoxide (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population) | Visit 4 | -0.8 percent change from baseline | Standard Deviation 44.65 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population) | Visit 5 | -5.8 percent change from baseline | Standard Deviation 37.05 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population) | Visit 6 | 3.5 percent change from baseline | Standard Deviation 49.07 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population) | End of Study/Early Termination | -3.1 percent change from baseline | Standard Deviation 47 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population) | End of Study/Early Termination | 9.0 percent change from baseline | Standard Deviation 66.04 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population) | Visit 4 | 12.0 percent change from baseline | Standard Deviation 65.86 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population) | Visit 6 | 13.9 percent change from baseline | Standard Deviation 57.42 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population) | Visit 5 | 11.4 percent change from baseline | Standard Deviation 54.87 |
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxidep-value: 0.204895% CI: [-30.9, 6.68]t-test, 2 sided
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to control in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to control in exhaled carbon monoxidep-value: 0.473195% CI: [-27.4, 12.8]t-test, 2 sided
Secondary
Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population)
Summary statistics of percent change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population) | Visit 4 | 3.2 percent change from baseline | Standard Deviation 37.85 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population) | Visit 5 | 18.7 percent change from baseline | Standard Deviation 57.95 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population) | Visit 6 | 15.7 percent change from baseline | Standard Deviation 54.02 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population) | End of Study/Early Termination | 25.2 percent change from baseline | Standard Deviation 65.08 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population) | End of Study/Early Termination | 35.5 percent change from baseline | Standard Deviation 60.54 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population) | Visit 4 | 14.8 percent change from baseline | Standard Deviation 51.81 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population) | Visit 6 | 30.8 percent change from baseline | Standard Deviation 53.08 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population) | Visit 5 | 26.3 percent change from baseline | Standard Deviation 50.78 |
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalentsp-value: 0.40695% CI: [-33.2, 13.5]t-test, 2 sided
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalentsp-value: 0.416595% CI: [-35.4, 14.7]t-test, 2 sided
Secondary
Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population)
Summary statistics of percent change from Baseline for urinary S-phenyl mercapturic acid \[S-PMA\] (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Population: Per-protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population) | Visit 4 | 17.5 percent change from baseline | Standard Deviation 67.39 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population) | Visit 5 | 13.4 percent change from baseline | Standard Deviation 67.41 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population) | Visit 6 | 19.7 percent change from baseline | Standard Deviation 60.6 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population) | End of Study/Early Termination | 20.9 percent change from baseline | Standard Deviation 76.27 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population) | End of Study/Early Termination | 39.1 percent change from baseline | Standard Deviation 70.93 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population) | Visit 4 | 21.1 percent change from baseline | Standard Deviation 77.37 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population) | Visit 6 | 44.4 percent change from baseline | Standard Deviation 87.87 |
| Control (no VBM-FG2) | Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population) | Visit 5 | 38.2 percent change from baseline | Standard Deviation 69.68 |
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMAp-value: 0.152495% CI: [-45.1, 7.12]t-test, 2 sided
Comparison: Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMAp-value: 0.401495% CI: [-40.4, 16.3]t-test, 2 sided
Secondary
Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits
Summary statistics of urinary S-PMA (ng/g creatinine) in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented.
Time frame: Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)
Population: The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (ad Libitum VBM-FG2) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Missing | 2389.46 ng/g | Standard Deviation 964.418 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | No Change | 5283.54 ng/g | Standard Deviation 4043.599 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 5647.56 ng/g | Standard Deviation 1738.94 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Increase | 7331.62 ng/g | Standard Deviation 6411.996 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 6422.25 ng/g | Standard Deviation 6830.753 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Overall | 6072.78 ng/g | Standard Deviation 6251.565 |
| Test (ad Libitum VBM-FG2) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 2925.07 ng/g | Standard Deviation 3765.497 |
| Control (no VBM-FG2) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | No Change | 5743.41 ng/g | Standard Deviation 2819.277 |
| Control (no VBM-FG2) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5449.38 ng/g | Standard Deviation 5289.323 |
| Control (no VBM-FG2) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5374.40 ng/g | Standard Deviation 4875.645 |
| Control (no VBM-FG2) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5283.78 ng/g | Standard Deviation 4744.807 |
| Test (Visit 5) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 6495.06 ng/g | Standard Deviation 5936.803 |
| Test (Visit 5) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5731.61 ng/g | Standard Deviation 5064.881 |
| Test (Visit 5) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5991.56 ng/g | Standard Deviation 5741.49 |
| Test (Visit 5) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Missing | 2693.13 ng/g | Standard Deviation 1334.197 |
| Test (Visit 5) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 5510.19 ng/g | Standard Deviation 123.439 |
| Test (Visit 5) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | No Change | 4216.93 ng/g | Standard Deviation 2660.723 |
| Test (Visit 5) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 5352.66 ng/g | Standard Deviation 8413.472 |
| Control (Visit 5) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Increase | 4934.00 ng/g | Standard Deviation 4812.35 |
| Control (Visit 5) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5195.78 ng/g | Standard Deviation 4999.201 |
| Control (Visit 5) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5356.63 ng/g | Standard Deviation 5359.524 |
| Control (Visit 5) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | No Change | 6930.38 ng/g | Standard Deviation 5483.666 |
| Test (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | No Change | 6412.49 ng/g | Standard Deviation 4323.454 |
| Test (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6793.00 ng/g | Standard Deviation 6076.28 |
| Test (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 6848.24 ng/g | Standard Deviation 6467.601 |
| Test (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 5151.19 ng/g | Standard Deviation 6608.284 |
| Test (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 2265.42 ng/g | Standard Deviation 2731.172 |
| Test (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Missing | 2482.52 ng/g | Standard Deviation 208.398 |
| Test (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Overall | 6431.69 ng/g | Standard Deviation 6100.377 |
| Control (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5315.31 ng/g | Standard Deviation 6041.242 |
| Control (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | No Change | 5649.83 ng/g | Standard Deviation 1833.54 |
| Control (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5677.37 ng/g | Standard Deviation 5562.787 |
| Control (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5961.02 ng/g | Standard Deviation 5470.426 |
| Test (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | No Change | 6158.33 ng/g | Standard Deviation 5186.584 |
| Test (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Increase | 7572.53 ng/g | Standard Deviation 9023.363 |
| Test (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Missing | 2450.90 ng/g | Standard Deviation 1729.041 |
| Test (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 4892.41 ng/g | Standard Deviation 7615.7 |
| Test (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 731.08 ng/g | — |
| Test (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Overall | 7151.83 ng/g | Standard Deviation 8160.286 |
| Test (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 7836.17 ng/g | Standard Deviation 8644.447 |
| Control (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Overall | 5928.95 ng/g | Standard Deviation 5068.858 |
| Control (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 5399.55 ng/g | Standard Deviation 4159.097 |
| Control (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | No Change | 6108.42 ng/g | Standard Deviation 1258.428 |
| Control (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6342.74 ng/g | Standard Deviation 5917.203 |
| Test (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 7230.42 ng/g | Standard Deviation 9546.409 |
| Test (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Missing | 2144.28 ng/g | Standard Deviation 1851.862 |
| Test (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 533.76 ng/g | Standard Deviation 461.885 |
| Test (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Overall | 7525.25 ng/g | Standard Deviation 7893.011 |
| Test (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 8304.71 ng/g | Standard Deviation 8562.548 |
| Test (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | No Change | 8118.69 ng/g | Standard Deviation 5998.806 |
| Test (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Increase | 5863.90 ng/g | Standard Deviation 5274.304 |
| Control (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Overall | 6926.73 ng/g | Standard Deviation 6941.824 |
| Control (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Increase | 7369.19 ng/g | Standard Deviation 6552.358 |
| Control (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 6567.55 ng/g | Standard Deviation 7807.345 |
| Control (Visit 6) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | No Change | 4683.26 ng/g | Standard Deviation 7.859 |
| Test (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Overall | 7098.86 ng/g | Standard Deviation 7113.465 |
| Test (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | 100% Reduction | 440.59 ng/g | Standard Deviation 225.383 |
| Test (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | 50% to < 100% Reduction | 9795.94 ng/g | Standard Deviation 12602.08 |
| Test (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | No Change | 4352.99 ng/g | Standard Deviation 3873.342 |
| Test (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Missing | 2896.76 ng/g | Standard Deviation 1518.588 |
| Test (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Increase | 8389.80 ng/g | Standard Deviation 6625.523 |
| Test (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 7335.57 ng/g | Standard Deviation 7068.643 |
| Control (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | <50% Reduction | 6481.35 ng/g | Standard Deviation 6132.009 |
| Control (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Overall | 6502.50 ng/g | Standard Deviation 5540.461 |
| Control (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | No Change | 8688.22 ng/g | Standard Deviation 3272.243 |
| Control (End of Study) | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Increase | 6358.61 ng/g | Standard Deviation 5253.083 |