Trial Outcomes & Findings for A Study to Evaluate Changes in Smokers Using An Oral Tobacco-Derived Nicotine Product (NCT NCT04079933)
NCT ID: NCT04079933
Last Updated: 2024-09-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
154 participants
Primary outcome timeframe
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)
Results posted on
2024-09-27
Participant Flow
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 Three subjects were withdrawn from the study prior to randomization.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.
Participant milestones
| Measure |
Test (ad Libitum VERVE® Discs Blue Mint [VBM-FG2] Use)
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.
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Control (no VBM-FG2)
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
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|---|---|---|
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Overall Study
STARTED
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92
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62
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Overall Study
COMPLETED
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89
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57
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Overall Study
NOT COMPLETED
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3
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5
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Reasons for withdrawal
| Measure |
Test (ad Libitum VERVE® Discs Blue Mint [VBM-FG2] Use)
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.
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Control (no VBM-FG2)
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
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|---|---|---|
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Overall Study
Withdrawal by Subject
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3
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4
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Overall Study
Lost to Follow-up
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0
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1
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Baseline Characteristics
Intent to Treat population. Data was not available for four subjects.
Baseline characteristics by cohort
| Measure |
Test (ad Libitum VBM-FG2)
n=92 Participants
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
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Control (no VBM-FG2)
n=62 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
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Total
n=154 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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43 years
n=92 Participants
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42 years
n=62 Participants
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43 years
n=154 Participants
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Sex: Female, Male
Female
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48 Participants
n=92 Participants
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30 Participants
n=62 Participants
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78 Participants
n=154 Participants
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Sex: Female, Male
Male
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44 Participants
n=92 Participants
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32 Participants
n=62 Participants
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76 Participants
n=154 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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6 Participants
n=92 Participants
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3 Participants
n=62 Participants
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9 Participants
n=154 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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86 Participants
n=92 Participants
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59 Participants
n=62 Participants
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145 Participants
n=154 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=92 Participants
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0 Participants
n=62 Participants
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0 Participants
n=154 Participants
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Race/Ethnicity, Customized
Race · Asian
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1 Participants
n=92 Participants
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0 Participants
n=62 Participants
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1 Participants
n=154 Participants
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Race/Ethnicity, Customized
Race · Black or African American
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15 Participants
n=92 Participants
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11 Participants
n=62 Participants
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26 Participants
n=154 Participants
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Race/Ethnicity, Customized
Race · White
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72 Participants
n=92 Participants
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47 Participants
n=62 Participants
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119 Participants
n=154 Participants
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Race/Ethnicity, Customized
Race · Other
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4 Participants
n=92 Participants
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4 Participants
n=62 Participants
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8 Participants
n=154 Participants
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Body Weight
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82.8 kg
STANDARD_DEVIATION 20.94 • n=92 Participants
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85.3 kg
STANDARD_DEVIATION 23.56 • n=62 Participants
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83.8 kg
STANDARD_DEVIATION 21.99 • n=154 Participants
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Height
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170.8 cm
STANDARD_DEVIATION 8.32 • n=92 Participants
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171.1 cm
STANDARD_DEVIATION 9.40 • n=62 Participants
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170.9 cm
STANDARD_DEVIATION 8.75 • n=154 Participants
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BMI
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28.3 kg/m^2
STANDARD_DEVIATION 6.69 • n=92 Participants
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29.0 kg/m^2
STANDARD_DEVIATION 7.26 • n=62 Participants
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28.6 kg/m^2
STANDARD_DEVIATION 6.91 • n=154 Participants
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Quit Attempts
Yes
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3 Participants
n=92 Participants
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3 Participants
n=62 Participants
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6 Participants
n=154 Participants
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Quit Attempts
No
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89 Participants
n=92 Participants
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59 Participants
n=62 Participants
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148 Participants
n=154 Participants
|
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Cigarette Consumption per Day
≤ 20
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66 Participants
n=92 Participants
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44 Participants
n=62 Participants
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110 Participants
n=154 Participants
|
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Cigarette Consumption per Day
>20
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26 Participants
n=92 Participants
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18 Participants
n=62 Participants
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44 Participants
n=154 Participants
|
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Quit Attempts in previous 6 months
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0.3 smoking cessations
STANDARD_DEVIATION 0.89 • n=89 Participants • Intent to Treat population. Data was not available for four subjects.
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0.2 smoking cessations
STANDARD_DEVIATION 0.67 • n=61 Participants • Intent to Treat population. Data was not available for four subjects.
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0.3 smoking cessations
STANDARD_DEVIATION 0.81 • n=150 Participants • Intent to Treat population. Data was not available for four subjects.
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Number of years smoked since turning 21 years of age
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19.5 years
STANDARD_DEVIATION 10.99 • n=91 Participants • Intent to Treat population. Data was not available for three subjects.
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20.3 years
STANDARD_DEVIATION 10.30 • n=60 Participants • Intent to Treat population. Data was not available for three subjects.
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19.8 years
STANDARD_DEVIATION 10.69 • n=151 Participants • Intent to Treat population. Data was not available for three subjects.
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PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
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Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
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Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
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Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
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Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
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Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
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Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
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Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
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Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
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Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
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Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
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Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
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Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
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Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
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Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
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Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population)
Visit 6
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16.0 percent change from baseline
Standard Deviation 50.87
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29.2 percent change from baseline
Standard Deviation 46.70
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Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population)
Visit 4
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3.8 percent change from baseline
Standard Deviation 34.11
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13.8 percent change from baseline
Standard Deviation 45.56
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Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population)
Visit 5
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12.5 percent change from baseline
Standard Deviation 60.16
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30.4 percent change from baseline
Standard Deviation 63.66
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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
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15.4 percent change from baseline
Standard Deviation 62.42
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28.4 percent change from baseline
Standard Deviation 57.66
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SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
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Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
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Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
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Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
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Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
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Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
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Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
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Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
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Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
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Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
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Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
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Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
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Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
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Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
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Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population)
End of Study/Early Termination
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81.33 ng/g
Standard Deviation 345.110
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86.53 ng/g
Standard Deviation 209.749
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Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population)
Visit 4
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14.99 ng/g
Standard Deviation 212.505
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9.47 ng/g
Standard Deviation 207.308
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Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population)
Visit 5
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70.90 ng/g
Standard Deviation 436.326
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76.50 ng/g
Standard Deviation 310.423
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Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population)
Visit 6
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66.23 ng/g
Standard Deviation 303.806
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117.69 ng/g
Standard Deviation 289.763
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SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
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Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
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Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
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Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
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Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
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Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
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Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
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Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
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Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
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Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
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Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
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Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
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Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
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Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
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Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population)
Visit 4
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-0.6 mg/g
Standard Deviation 5.28
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0.6 mg/g
Standard Deviation 6.45
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Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population)
Visit 5
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1.9 mg/g
Standard Deviation 8.46
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2.5 mg/g
Standard Deviation 6.48
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Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population)
Visit 6
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1.1 mg/g
Standard Deviation 8.03
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4.3 mg/g
Standard Deviation 9.47
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Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population)
End of Study/Early Termination
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2.6 mg/g
Standard Deviation 9.75
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3.6 mg/g
Standard Deviation 6.89
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SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
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Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
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Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
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Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
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Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
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Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
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Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
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Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
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Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
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Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
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Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
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Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
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Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
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Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
14.8 percent change from baseline
Standard Deviation 51.81
|
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
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
|
26.3 percent change from baseline
Standard Deviation 50.78
|
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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
|
30.8 percent change from baseline
Standard Deviation 53.08
|
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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
|
35.5 percent change from baseline
Standard Deviation 60.54
|
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SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
242.66 ng/g
Standard Deviation 2846.817
|
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—
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|
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
|
809.04 ng/g
Standard Deviation 3649.614
|
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|
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
|
1637.29 ng/g
Standard Deviation 4348.050
|
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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
|
1160.48 ng/g
Standard Deviation 2798.644
|
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SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
21.1 percent change from baseline
Standard Deviation 77.37
|
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|
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
|
38.2 percent change from baseline
Standard Deviation 69.68
|
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|
Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population)
Visit 6
|
19.7 percent change from baseline
Standard Deviation 60.60
|
44.4 percent change from baseline
Standard Deviation 87.87
|
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|
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
|
39.1 percent change from baseline
Standard Deviation 70.93
|
—
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—
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—
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|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)
Visit 4
|
-0.42 percent saturation of carboxyhemoglobin
Standard Deviation 1.449
|
0.03 percent saturation of carboxyhemoglobin
Standard Deviation 1.460
|
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Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)
Visit 5
|
-0.24 percent saturation of carboxyhemoglobin
Standard Deviation 1.418
|
0.39 percent saturation of carboxyhemoglobin
Standard Deviation 1.374
|
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Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)
Visit 6
|
-0.02 percent saturation of carboxyhemoglobin
Standard Deviation 1.547
|
0.39 percent saturation of carboxyhemoglobin
Standard Deviation 1.299
|
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|
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
|
-0.10 percent saturation of carboxyhemoglobin
Standard Deviation 1.118
|
—
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—
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—
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—
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|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)
Visit 4
|
-6.3 percent change from baseline
Standard Deviation 27.48
|
5.3 percent change from baseline
Standard Deviation 35.59
|
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|
Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)
Visit 5
|
-4.0 percent change from baseline
Standard Deviation 26.17
|
9.8 percent change from baseline
Standard Deviation 27.21
|
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Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)
Visit 6
|
1.4 percent change from baseline
Standard Deviation 28.26
|
11.3 percent change from baseline
Standard Deviation 29.44
|
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|
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
|
0.7 percent change from baseline
Standard Deviation 25.53
|
—
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—
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|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population)
Visit 4
|
-1.4 ppm
Standard Deviation 9.41
|
-0.2 ppm
Standard Deviation 7.84
|
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Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population)
Visit 5
|
-1.9 ppm
Standard Deviation 7.48
|
0.7 ppm
Standard Deviation 8.37
|
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—
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—
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—
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—
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—
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|
Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population)
Visit 6
|
-0.8 ppm
Standard Deviation 9.30
|
0.6 ppm
Standard Deviation 7.89
|
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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
|
-0.8 ppm
Standard Deviation 6.90
|
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SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
12.0 percent change from baseline
Standard Deviation 65.86
|
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—
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|
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
|
11.4 percent change from baseline
Standard Deviation 54.87
|
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|
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
|
13.9 percent change from baseline
Standard Deviation 57.42
|
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|
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 47.00
|
9.0 percent change from baseline
Standard Deviation 66.04
|
—
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—
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SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
0.5 cigarettes per day
Standard Deviation 1.96
|
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—
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—
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|
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
|
0.3 cigarettes per day
Standard Deviation 2.37
|
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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
|
0.3 cigarettes per day
Standard Deviation 2.78
|
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|
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
|
0.4 cigarettes per day
Standard Deviation 2.76
|
—
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SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
2.9 percent change from baseline
Standard Deviation 15.18
|
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—
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—
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—
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—
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|
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 19.30
|
3.1 percent change from baseline
Standard Deviation 10.85
|
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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
|
2.9 percent change from baseline
Standard Deviation 18.01
|
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|
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
|
3.2 percent change from baseline
Standard Deviation 17.28
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)Population: 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
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=86 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
0.0 scores on a scale
Standard Deviation 0.82
|
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SECONDARY outcome
Timeframe: Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)Population: Per-protocol population
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quit Attempts (Per-Protocol)
Increase
|
4 Participants
|
0 Participants
|
—
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—
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—
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—
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—
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—
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|
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
|
53 Participants
|
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—
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—
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Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quit Attempts (Per-Protocol)
Decrease
|
1 Participants
|
2 Participants
|
—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)Population: Per-protocol population
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=86 Participants
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
|
Control (no VBM-FG2)
n=50 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quitting Intentions (Per-Protocol)
Same
|
74 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=138 Participants
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
|
Control (no VBM-FG2)
n=138 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Difference in Means of Urinary Total NNAL Exposure Between Day 1 and Day 8 (Per-Protocol)
|
485.0 ng/g
Standard Deviation 348.45
|
495.0 ng/g
Standard Deviation 358.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=122 Participants
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
|
Control (no VBM-FG2)
n=122 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Difference in Means of Nicotine Equivalents Exposure Between Day 1 and Day 8 (Per-Protocol)
|
13.29 mg/g
Standard Deviation 9.138
|
13.74 mg/g
Standard Deviation 9.049
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=136 Participants
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
|
Control (no VBM-FG2)
n=136 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Difference in Means of S-PMA Exposure Between Day 1 and Day 8 (Per-Protocol)
|
5773 ng/g
Standard Deviation 5786.3
|
5567 ng/g
Standard Deviation 5222.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=142 Participants
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
|
Control (no VBM-FG2)
n=142 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
5.4 percent saturation of carboxyhemoglobin
Standard Deviation 1.96
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=142 Participants
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
|
Control (no VBM-FG2)
n=142 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Difference in Means of Carbon Monoxide (CO) Exposure Between Day 1 and Day 8 (Per-Protocol)
|
22 ppm
Standard Deviation 10.0
|
22 ppm
Standard Deviation 10.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=129 Participants
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
|
Control (no VBM-FG2)
n=129 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
19 cigarettes per day
Standard Deviation 6.3
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)Population: Per-protocol population
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).
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
n=85 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption
No Change
|
5 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
8 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption
<50% Reduction
|
67 Participants
|
22 Participants
|
62 Participants
|
21 Participants
|
56 Participants
|
25 Participants
|
57 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption
50% to < 100%
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption
100% Reduction
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption
Increase
|
12 Participants
|
30 Participants
|
14 Participants
|
30 Participants
|
17 Participants
|
26 Participants
|
10 Participants
|
29 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)Population: Per-protocol population
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine)
No Change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine)
Reduction
|
45 Participants
|
25 Participants
|
40 Participants
|
18 Participants
|
33 Participants
|
16 Participants
|
38 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine)
Increase
|
35 Participants
|
28 Participants
|
43 Participants
|
33 Participants
|
46 Participants
|
37 Participants
|
46 Participants
|
36 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine)
Missing
|
7 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)Population: Per-protocol population
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)
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=86 Participants
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
|
Control (no VBM-FG2)
n=50 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions
No to Yes
|
12 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions
Yes to No
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions
Same
|
74 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Visit 2) and Day 8 (Visit 3)Population: Per-protocol population
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=74 Participants
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
|
Control (no VBM-FG2)
n=50 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=79 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=50 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
19.8 cigarettes per day
Standard Deviation 7.64
|
17.6 cigarettes per day
Standard Deviation 5.36
|
20.0 cigarettes per day
Standard Deviation 7.43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
n=86 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
n=87 Participants
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
n=55 Participants
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
n=87 Participants
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
n=55 Participants
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits
Increase
|
6.5 percent saturation of carboxyhemoglobin
Standard Deviation 2.61
|
5.5 percent saturation of carboxyhemoglobin
Standard Deviation 2.10
|
6.6 percent saturation of carboxyhemoglobin
Standard Deviation 2.15
|
5.3 percent saturation of carboxyhemoglobin
Standard Deviation 1.63
|
6.2 percent saturation of carboxyhemoglobin
Standard Deviation 2.15
|
5.5 percent saturation of carboxyhemoglobin
Standard Deviation 1.65
|
6.8 percent saturation of carboxyhemoglobin
Standard Deviation 2.46
|
6.1 percent saturation of carboxyhemoglobin
Standard Deviation 2.26
|
6.6 percent saturation of carboxyhemoglobin
Standard Deviation 2.15
|
5.8 percent saturation of carboxyhemoglobin
Standard Deviation 2.07
|
6.0 percent saturation of carboxyhemoglobin
Standard Deviation 1.80
|
5.4 percent saturation of carboxyhemoglobin
Standard Deviation 1.79
|
—
|
—
|
—
|
—
|
|
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
|
3.9 percent saturation of carboxyhemoglobin
Standard Deviation 0.14
|
5.7 percent saturation of carboxyhemoglobin
Standard Deviation 2.15
|
3.7 percent saturation of carboxyhemoglobin
Standard Deviation 2.19
|
5.2 percent saturation of carboxyhemoglobin
Standard Deviation 1.73
|
3.3 percent saturation of carboxyhemoglobin
Standard Deviation 0.14
|
5.2 percent saturation of carboxyhemoglobin
Standard Deviation 1.76
|
3.2 percent saturation of carboxyhemoglobin
Standard Deviation 0.07
|
4.9 percent saturation of carboxyhemoglobin
Standard Deviation 1.42
|
5.6 percent saturation of carboxyhemoglobin
Standard Deviation 3.11
|
5.0 percent saturation of carboxyhemoglobin
Standard Deviation 1.28
|
4.6 percent saturation of carboxyhemoglobin
Standard Deviation 1.41
|
—
|
—
|
—
|
—
|
|
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
|
5.0 percent saturation of carboxyhemoglobin
Standard Deviation 2.35
|
5.4 percent saturation of carboxyhemoglobin
Standard Deviation 1.92
|
5.0 percent saturation of carboxyhemoglobin
Standard Deviation 2.18
|
5.2 percent saturation of carboxyhemoglobin
Standard Deviation 2.05
|
4.8 percent saturation of carboxyhemoglobin
Standard Deviation 2.15
|
5.4 percent saturation of carboxyhemoglobin
Standard Deviation 2.24
|
5.0 percent saturation of carboxyhemoglobin
Standard Deviation 2.08
|
5.8 percent saturation of carboxyhemoglobin
Standard Deviation 2.28
|
5.1 percent saturation of carboxyhemoglobin
Standard Deviation 1.82
|
5.1 percent saturation of carboxyhemoglobin
Standard Deviation 2.07
|
4.6 percent saturation of carboxyhemoglobin
Standard Deviation 1.85
|
—
|
—
|
—
|
—
|
|
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
|
—
|
5.4 percent saturation of carboxyhemoglobin
Standard Deviation 2.16
|
—
|
4.7 percent saturation of carboxyhemoglobin
Standard Deviation 2.03
|
—
|
4.4 percent saturation of carboxyhemoglobin
Standard Deviation 1.98
|
—
|
3.7 percent saturation of carboxyhemoglobin
Standard Deviation 1.90
|
—
|
3.2 percent saturation of carboxyhemoglobin
Standard Deviation 1.87
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
4.5 percent saturation of carboxyhemoglobin
Standard Deviation 0.35
|
—
|
2.0 percent saturation of carboxyhemoglobin
Standard Deviation 0.64
|
—
|
1.2 percent saturation of carboxyhemoglobin
Standard Deviation 0.21
|
—
|
1.2 percent saturation of carboxyhemoglobin
Standard Deviation 0.00
|
—
|
1.5 percent saturation of carboxyhemoglobin
Standard Deviation 0.21
|
—
|
—
|
—
|
—
|
—
|
|
Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits
Missing
|
3.5 percent saturation of carboxyhemoglobin
Standard Deviation 1.63
|
—
|
4.3 percent saturation of carboxyhemoglobin
Standard Deviation 2.33
|
—
|
2.2 percent saturation of carboxyhemoglobin
Standard Deviation 0.14
|
—
|
3.3 percent saturation of carboxyhemoglobin
Standard Deviation 1.98
|
—
|
4.1 percent saturation of carboxyhemoglobin
Standard Deviation 1.91
|
—
|
3.7 percent saturation of carboxyhemoglobin
Standard Deviation 0.92
|
—
|
—
|
—
|
—
|
—
|
|
Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits
Overall
|
5.4 percent saturation of carboxyhemoglobin
Standard Deviation 2.11
|
5.3 percent saturation of carboxyhemoglobin
Standard Deviation 2.18
|
5.5 percent saturation of carboxyhemoglobin
Standard Deviation 1.99
|
5.1 percent saturation of carboxyhemoglobin
Standard Deviation 1.90
|
5.1 percent saturation of carboxyhemoglobin
Standard Deviation 2.10
|
5.1 percent saturation of carboxyhemoglobin
Standard Deviation 1.91
|
5.3 percent saturation of carboxyhemoglobin
Standard Deviation 2.32
|
5.5 percent saturation of carboxyhemoglobin
Standard Deviation 2.23
|
5.5 percent saturation of carboxyhemoglobin
Standard Deviation 2.33
|
5.5 percent saturation of carboxyhemoglobin
Standard Deviation 1.98
|
4.9 percent saturation of carboxyhemoglobin
Standard Deviation 2.07
|
5.0 percent saturation of carboxyhemoglobin
Standard Deviation 1.82
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
n=87 Participants
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
n=55 Participants
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
n=87 Participants
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
n=55 Participants
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
—
|
20.6 ppm
Standard Deviation 9.86
|
—
|
18.0 ppm
Standard Deviation 8.83
|
—
|
15.5 ppm
Standard Deviation 8.38
|
—
|
12.1 ppm
Standard Deviation 8.54
|
—
|
9.9 ppm
Standard Deviation 6.08
|
—
|
—
|
—
|
—
|
—
|
|
Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits
100% Reduction
|
20.0 ppm
Standard Deviation 5.66
|
—
|
17.0 ppm
Standard Deviation 4.24
|
—
|
4.5 ppm
Standard Deviation 0.71
|
—
|
2.5 ppm
Standard Deviation 0.71
|
—
|
5.5 ppm
Standard Deviation 2.12
|
—
|
4.0 ppm
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
—
|
|
Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits
<50% Reduction
|
22.2 ppm
Standard Deviation 9.21
|
22.3 ppm
Standard Deviation 10.87
|
21.6 ppm
Standard Deviation 10.01
|
21.0 ppm
Standard Deviation 11.13
|
20.9 ppm
Standard Deviation 11.16
|
19.4 ppm
Standard Deviation 10.89
|
20.5 ppm
Standard Deviation 10.25
|
19.9 ppm
Standard Deviation 9.98
|
23.0 ppm
Standard Deviation 11.32
|
20.4 ppm
Standard Deviation 9.24
|
21.1 ppm
Standard Deviation 10.09
|
19.1 ppm
Standard Deviation 8.71
|
—
|
—
|
—
|
—
|
|
Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits
Increase
|
28.3 ppm
Standard Deviation 11.13
|
21.0 ppm
Standard Deviation 9.65
|
29.6 ppm
Standard Deviation 12.12
|
20.6 ppm
Standard Deviation 9.11
|
28.5 ppm
Standard Deviation 15.29
|
21.4 ppm
Standard Deviation 8.57
|
28.1 ppm
Standard Deviation 13.60
|
22.7 ppm
Standard Deviation 13.28
|
27.8 ppm
Standard Deviation 12.32
|
21.8 ppm
Standard Deviation 10.44
|
25.9 ppm
Standard Deviation 8.86
|
20.2 ppm
Standard Deviation 9.54
|
—
|
—
|
—
|
—
|
|
Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits
No Change
|
17.3 ppm
Standard Deviation 10.77
|
15.5 ppm
Standard Deviation 3.54
|
22.5 ppm
Standard Deviation 9.56
|
11.5 ppm
Standard Deviation 10.61
|
21.6 ppm
Standard Deviation 8.88
|
12.0 ppm
Standard Deviation 4.24
|
22.4 ppm
Standard Deviation 10.88
|
11.5 ppm
Standard Deviation 2.12
|
19.3 ppm
Standard Deviation 9.82
|
18.0 ppm
Standard Deviation 9.90
|
21.5 ppm
Standard Deviation 9.96
|
18.5 ppm
Standard Deviation 2.12
|
—
|
—
|
—
|
—
|
|
Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits
Missing
|
20.5 ppm
Standard Deviation 14.85
|
—
|
18.5 ppm
Standard Deviation 16.26
|
—
|
10.5 ppm
Standard Deviation 2.12
|
—
|
9.5 ppm
Standard Deviation 6.36
|
—
|
15.5 ppm
Standard Deviation 12.02
|
—
|
13.0 ppm
Standard Deviation 8.49
|
—
|
—
|
—
|
—
|
—
|
|
Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits
Overall
|
22.1 ppm
Standard Deviation 10.05
|
21.4 ppm
Standard Deviation 10.03
|
22.4 ppm
Standard Deviation 10.40
|
20.4 ppm
Standard Deviation 10.05
|
21.0 ppm
Standard Deviation 11.68
|
20.2 ppm
Standard Deviation 9.62
|
20.5 ppm
Standard Deviation 11.18
|
21.1 ppm
Standard Deviation 11.81
|
21.7 ppm
Standard Deviation 11.71
|
21.0 ppm
Standard Deviation 9.77
|
20.1 ppm
Standard Deviation 10.41
|
19.7 ppm
Standard Deviation 8.94
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=85 Participants
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
|
Control (no VBM-FG2)
n=54 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=84 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=54 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=80 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=50 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
n=84 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
n=49 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
n=77 Participants
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
n=52 Participants
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
n=83 Participants
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
n=52 Participants
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits
Increase
|
7331.62 ng/g
Standard Deviation 6411.996
|
5283.78 ng/g
Standard Deviation 4744.807
|
5731.61 ng/g
Standard Deviation 5064.881
|
4934.00 ng/g
Standard Deviation 4812.350
|
6793.00 ng/g
Standard Deviation 6076.280
|
5961.02 ng/g
Standard Deviation 5470.426
|
7572.53 ng/g
Standard Deviation 9023.363
|
6342.74 ng/g
Standard Deviation 5917.203
|
5863.90 ng/g
Standard Deviation 5274.304
|
7369.19 ng/g
Standard Deviation 6552.358
|
8389.80 ng/g
Standard Deviation 6625.523
|
6358.61 ng/g
Standard Deviation 5253.083
|
—
|
—
|
—
|
—
|
|
Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits
No Change
|
5283.54 ng/g
Standard Deviation 4043.599
|
5743.41 ng/g
Standard Deviation 2819.277
|
4216.93 ng/g
Standard Deviation 2660.723
|
6930.38 ng/g
Standard Deviation 5483.666
|
6412.49 ng/g
Standard Deviation 4323.454
|
5649.83 ng/g
Standard Deviation 1833.540
|
6158.33 ng/g
Standard Deviation 5186.584
|
6108.42 ng/g
Standard Deviation 1258.428
|
8118.69 ng/g
Standard Deviation 5998.806
|
4683.26 ng/g
Standard Deviation 7.859
|
4352.99 ng/g
Standard Deviation 3873.342
|
8688.22 ng/g
Standard Deviation 3272.243
|
—
|
—
|
—
|
—
|
|
Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits
<50% Reduction
|
6422.25 ng/g
Standard Deviation 6830.753
|
5449.38 ng/g
Standard Deviation 5289.323
|
6495.06 ng/g
Standard Deviation 5936.803
|
5356.63 ng/g
Standard Deviation 5359.524
|
6848.24 ng/g
Standard Deviation 6467.601
|
5315.31 ng/g
Standard Deviation 6041.242
|
7836.17 ng/g
Standard Deviation 8644.447
|
5399.55 ng/g
Standard Deviation 4159.097
|
8304.71 ng/g
Standard Deviation 8562.548
|
6567.55 ng/g
Standard Deviation 7807.345
|
7335.57 ng/g
Standard Deviation 7068.643
|
6481.35 ng/g
Standard Deviation 6132.009
|
—
|
—
|
—
|
—
|
|
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
|
—
|
5352.66 ng/g
Standard Deviation 8413.472
|
—
|
5151.19 ng/g
Standard Deviation 6608.284
|
—
|
4892.41 ng/g
Standard Deviation 7615.700
|
—
|
7230.42 ng/g
Standard Deviation 9546.409
|
—
|
9795.94 ng/g
Standard Deviation 12602.08
|
—
|
—
|
—
|
—
|
—
|
|
Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits
100% Reduction
|
5647.56 ng/g
Standard Deviation 1738.940
|
—
|
5510.19 ng/g
Standard Deviation 123.439
|
—
|
2265.42 ng/g
Standard Deviation 2731.172
|
—
|
731.08 ng/g
|
—
|
533.76 ng/g
Standard Deviation 461.885
|
—
|
440.59 ng/g
Standard Deviation 225.383
|
—
|
—
|
—
|
—
|
—
|
|
Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits
Missing
|
2389.46 ng/g
Standard Deviation 964.418
|
—
|
2693.13 ng/g
Standard Deviation 1334.197
|
—
|
2482.52 ng/g
Standard Deviation 208.398
|
—
|
2450.90 ng/g
Standard Deviation 1729.041
|
—
|
2144.28 ng/g
Standard Deviation 1851.862
|
—
|
2896.76 ng/g
Standard Deviation 1518.588
|
—
|
—
|
—
|
—
|
—
|
|
Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits
Overall
|
6072.78 ng/g
Standard Deviation 6251.565
|
5374.40 ng/g
Standard Deviation 4875.645
|
5991.56 ng/g
Standard Deviation 5741.490
|
5195.78 ng/g
Standard Deviation 4999.201
|
6431.69 ng/g
Standard Deviation 6100.377
|
5677.37 ng/g
Standard Deviation 5562.787
|
7151.83 ng/g
Standard Deviation 8160.286
|
5928.95 ng/g
Standard Deviation 5068.858
|
7525.25 ng/g
Standard Deviation 7893.011
|
6926.73 ng/g
Standard Deviation 6941.824
|
7098.86 ng/g
Standard Deviation 7113.465
|
6502.50 ng/g
Standard Deviation 5540.461
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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').
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=74 Participants
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
|
Control (no VBM-FG2)
n=50 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=79 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=50 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
19.7 cigarettes per day
Standard Deviation 8.52
|
16.1 cigarettes per day
Standard Deviation 4.68
|
19.9 cigarettes per day
Standard Deviation 8.47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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 8.80
|
20.0 cigarettes per day
Standard Deviation 0.00
|
17.6 cigarettes per day
Standard Deviation 8.28
|
20.0 cigarettes per day
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
19.8 cigarettes per day
Standard Deviation 6.96
|
18.2 cigarettes per day
Standard Deviation 4.94
|
20.2 cigarettes per day
Standard Deviation 6.36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
16.8 cigarettes per day
Standard Deviation 5.85
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
11.0 cigarettes per day
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
20.0 cigarettes per day
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
19.8 cigarettes per day
Standard Deviation 7.64
|
17.6 cigarettes per day
Standard Deviation 5.36
|
20.0 cigarettes per day
Standard Deviation 7.43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=86 Participants
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
|
Control (no VBM-FG2)
n=53 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=68 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=47 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=69 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=47 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
n=72 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
n=44 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
n=68 Participants
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
n=43 Participants
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
n=67 Participants
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
n=49 Participants
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
n=76 Participants
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
n=42 Participants
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
n=87 Participants
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
n=55 Participants
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
19.1 cigarettes per day
Standard Deviation 8.04
|
15.4 cigarettes per day
Standard Deviation 4.42
|
17.4 cigarettes per day
Standard Deviation 8.39
|
17.0 cigarettes per day
Standard Deviation 5.13
|
20.00 cigarettes per day
Standard Deviation 8.66
|
17.0 cigarettes per day
Standard Deviation 5.34
|
20.3 cigarettes per day
Standard Deviation 8.49
|
15.8 cigarettes per day
Standard Deviation 5.31
|
19.4 cigarettes per day
Standard Deviation 9.63
|
15.8 cigarettes per day
Standard Deviation 7.91
|
20.7 cigarettes per day
Standard Deviation 9.82
|
15.4 cigarettes per day
Standard Deviation 9.06
|
18.4 cigarettes per day
Standard Deviation 8.75
|
17.5 cigarettes per day
Standard Deviation 7.67
|
19.3 cigarettes per day
Standard Deviation 8.58
|
|
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
|
20.0 cigarettes per day
Standard Deviation 0.00
|
18.7 cigarettes per day
Standard Deviation 8.30
|
20.0 cigarettes per day
Standard Deviation 0.00
|
17.4 cigarettes per day
Standard Deviation 8.40
|
20.0 cigarettes per day
Standard Deviation 0.00
|
17.6 cigarettes per day
Standard Deviation 8.28
|
20.0 cigarettes per day
|
18.4 cigarettes per day
Standard Deviation 8.52
|
20.0 cigarettes per day
|
17.1 cigarettes per day
Standard Deviation 8.54
|
20.0 cigarettes per day
Standard Deviation 0.00
|
17.5 cigarettes per day
Standard Deviation 8.33
|
20.0 cigarettes per day
Standard Deviation 0.00
|
17.3 cigarettes per day
Standard Deviation 8.48
|
20.0 cigarettes per day
Standard Deviation 0.00
|
|
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
|
17.4 cigarettes per day
Standard Deviation 7.12
|
17.9 cigarettes per day
Standard Deviation 5.50
|
19.1 cigarettes per day
Standard Deviation 6.48
|
17.3 cigarettes per day
Standard Deviation 5.06
|
20.6 cigarettes per day
Standard Deviation 6.45
|
18.8 cigarettes per day
Standard Deviation 5.42
|
21.2 cigarettes per day
Standard Deviation 7.06
|
17.8 cigarettes per day
Standard Deviation 5.64
|
20.8 cigarettes per day
Standard Deviation 8.30
|
17.9 cigarettes per day
Standard Deviation 5.77
|
19.1 cigarettes per day
Standard Deviation 5.77
|
18.9 cigarettes per day
Standard Deviation 5.39
|
18.8 cigarettes per day
Standard Deviation 6.74
|
18.6 cigarettes per day
Standard Deviation 5.21
|
19.0 cigarettes per day
Standard Deviation 6.87
|
|
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
|
—
|
16.2 cigarettes per day
Standard Deviation 5.85
|
—
|
19.1 cigarettes per day
Standard Deviation 6.28
|
—
|
17.4 cigarettes per day
Standard Deviation 5.66
|
—
|
18.6 cigarettes per day
Standard Deviation 5.62
|
—
|
18.3 cigarettes per day
Standard Deviation 8.88
|
—
|
17.4 cigarettes per day
Standard Deviation 10.44
|
—
|
19.0 cigarettes per day
Standard Deviation 5.86
|
—
|
|
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
|
—
|
11.5 cigarettes per day
Standard Deviation 4.95
|
—
|
8.5 cigarettes per day
Standard Deviation 2.12
|
—
|
10.0 cigarettes per day
|
—
|
—
|
—
|
15.0 cigarettes per day
Standard Deviation 0.00
|
—
|
11.5 cigarettes per day
Standard Deviation 3.54
|
—
|
11.0 cigarettes per day
Standard Deviation 5.66
|
—
|
|
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
|
—
|
15.0 cigarettes per day
Standard Deviation 7.07
|
—
|
15.5 cigarettes per day
Standard Deviation 6.36
|
—
|
16.0 cigarettes per day
Standard Deviation 5.66
|
—
|
17.0 cigarettes per day
Standard Deviation 7.07
|
—
|
17.0 cigarettes per day
Standard Deviation 7.07
|
—
|
21.0 cigarettes per day
Standard Deviation 12.73
|
—
|
17.5 cigarettes per day
Standard Deviation 10.61
|
—
|
|
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
|
18.4 cigarettes per day
Standard Deviation 7.49
|
17.3 cigarettes per day
Standard Deviation 5.72
|
18.2 cigarettes per day
Standard Deviation 7.41
|
17.2 cigarettes per day
Standard Deviation 5.68
|
20.2 cigarettes per day
Standard Deviation 7.46
|
18.1 cigarettes per day
Standard Deviation 5.74
|
20.7 cigarettes per day
Standard Deviation 7.79
|
17.6 cigarettes per day
Standard Deviation 5.83
|
20.0 cigarettes per day
Standard Deviation 8.87
|
17.4 cigarettes per day
Standard Deviation 6.37
|
20.0 cigarettes per day
Standard Deviation 7.96
|
18.0 cigarettes per day
Standard Deviation 6.93
|
18.7 cigarettes per day
Standard Deviation 7.48
|
18.2 cigarettes per day
Standard Deviation 6.01
|
19.2 cigarettes per day
Standard Deviation 7.63
|
SECONDARY outcome
Timeframe: Day 8 (Visit 3) and End of Study (Day 36±1)Population: Per-Protocol Population
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group
|
472.893 ng/g
Interval 42.92 to 2072.61
|
395.108 ng/g
Interval 41.9 to 1524.88
|
444.709 ng/g
Interval 16.53 to 2851.85
|
476.795 ng/g
Interval 59.67 to 1558.82
|
5.448 ng/g
Interval -564.08 to 1872.75
|
70.129 ng/g
Interval -408.32 to 683.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=84 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=86 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=54 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=84 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=54 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories
Increase
|
548.817 ng/g
Interval 103.304 to 1289.911
|
415.790 ng/g
Interval 75.406 to 1238.478
|
719.799 ng/g
Interval 252.923 to 1424.581
|
489.729 ng/g
Interval 59.671 to 1188.119
|
168.889 ng/g
Interval -36.828 to 376.475
|
67.998 ng/g
Interval -325.835 to 638.215
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 132.328 to 843.698
|
789.559 ng/g
Interval 54.238 to 1524.88
|
376.087 ng/g
Interval 175.045 to 590.85
|
592.508 ng/g
Interval 68.451 to 1116.564
|
30.576 ng/g
Interval -467.611 to 54.268
|
-197.051 ng/g
Interval -408.315 to 14.213
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 42.916 to 2072.612
|
356.857 ng/g
Interval 41.901 to 1431.914
|
444.709 ng/g
Interval 18.574 to 2050.275
|
467.615 ng/g
Interval 84.686 to 1558.824
|
1.776 ng/g
Interval -564.082 to 1208.177
|
73.507 ng/g
Interval -111.025 to 683.712
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 57.698 to 979.102
|
—
|
263.677 ng/g
Interval 62.899 to 2851.852
|
—
|
-48.425 ng/g
Interval -365.303 to 1872.75
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 157.063 to 160.236
|
—
|
28.686 ng/g
Interval 16.528 to 40.844
|
—
|
-129.963 ng/g
Interval -140.535 to -119.392
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories
Missing
|
303.452 ng/g
Interval 124.886 to 482.019
|
—
|
268.140 ng/g
Interval 146.165 to 390.115
|
—
|
-35.312 ng/g
Interval -91.904 to 21.279
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories
Overall
|
472.893 ng/g
Interval 42.916 to 2072.612
|
395.108 ng/g
Interval 41.901 to 1524.88
|
444.709 ng/g
Interval 16.528 to 2851.852
|
476.795 ng/g
Interval 59.671 to 1558.824
|
5.448 ng/g
Interval -564.082 to 1872.75
|
70.129 ng/g
Interval -408.315 to 683.712
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=84 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=86 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=54 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=84 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=54 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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 318.270
|
440.36 ng/g
Standard Deviation 261.806
|
721.93 ng/g
Standard Deviation 327.377
|
538.09 ng/g
Standard Deviation 287.478
|
158.11 ng/g
Standard Deviation 140.443
|
92.60 ng/g
Standard Deviation 227.975
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
789.56 ng/g
Standard Deviation 1039.900
|
389.46 ng/g
Standard Deviation 170.153
|
592.51 ng/g
Standard Deviation 741.128
|
-66.92 ng/g
Standard Deviation 185.884
|
-197.05 ng/g
Standard Deviation 298.772
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
487.20 ng/g
Standard Deviation 378.047
|
614.61 ng/g
Standard Deviation 517.499
|
590.28 ng/g
Standard Deviation 451.453
|
88.22 ng/g
Standard Deviation 320.921
|
103.08 ng/g
Standard Deviation 170.772
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
592.73 ng/g
Standard Deviation 932.562
|
—
|
149.71 ng/g
Standard Deviation 713.457
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
28.69 ng/g
Standard Deviation 17.194
|
—
|
-129.96 ng/g
Standard Deviation 14.950
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
268.14 ng/g
Standard Deviation 172.499
|
—
|
-35.31 ng/g
Standard Deviation 80.032
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
473.50 ng/g
Standard Deviation 347.581
|
586.29 ng/g
Standard Deviation 525.084
|
563.30 ng/g
Standard Deviation 376.309
|
81.33 ng/g
Standard Deviation 345.110
|
86.53 ng/g
Standard Deviation 209.749
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=84 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=86 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=54 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=84 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=54 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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 318.270
|
440.36 percent change from baseline
Standard Deviation 261.806
|
721.93 percent change from baseline
Standard Deviation 327.377
|
538.09 percent change from baseline
Standard Deviation 287.478
|
43.2 percent change from baseline
Standard Deviation 49.11
|
31.7 percent change from baseline
Standard Deviation 66.12
|
—
|
—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
|
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
|
789.56 percent change from baseline
Standard Deviation 1039.900
|
389.46 percent change from baseline
Standard Deviation 170.153
|
592.51 percent change from baseline
Standard Deviation 741.128
|
-0.3 percent change from baseline
Standard Deviation 29.55
|
-0.3 percent change from baseline
Standard Deviation 37.46
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
|
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
|
487.20 percent change from baseline
Standard Deviation 378.047
|
614.61 percent change from baseline
Standard Deviation 517.499
|
590.28 percent change from baseline
Standard Deviation 451.453
|
17.6 percent change from baseline
Standard Deviation 63.88
|
26.9 percent change from baseline
Standard Deviation 48.80
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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|
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
|
—
|
592.73 percent change from baseline
Standard Deviation 932.562
|
—
|
7.3 percent change from baseline
Standard Deviation 80.69
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
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
|
—
|
28.69 percent change from baseline
Standard Deviation 17.194
|
—
|
-82.0 percent change from baseline
Standard Deviation 10.58
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
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
|
—
|
268.14 percent change from baseline
Standard Deviation 172.499
|
—
|
-1.0 percent change from baseline
Standard Deviation 25.53
|
—
|
—
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—
|
—
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—
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—
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—
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—
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—
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—
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—
|
|
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
|
473.50 percent change from baseline
Standard Deviation 347.581
|
586.29 percent change from baseline
Standard Deviation 525.084
|
563.30 percent change from baseline
Standard Deviation 376.309
|
15.4 percent change from baseline
Standard Deviation 62.42
|
28.4 percent change from baseline
Standard Deviation 57.66
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=80 Participants
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
|
Control (no VBM-FG2)
n=50 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=79 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=48 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=74 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=46 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
13.70 mg/g
Standard Deviation 7.870
|
24.84 mg/g
Standard Deviation 14.892
|
16.55 mg/g
Standard Deviation 6.791
|
6.77 mg/g
Standard Deviation 7.432
|
3.73 mg/g
Standard Deviation 5.932
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
8.14 mg/g
|
10.23 mg/g
Standard Deviation 3.053
|
13.62 mg/g
Standard Deviation 1.600
|
1.48 mg/g
Standard Deviation 3.418
|
6.61 mg/g
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
14.77 mg/g
Standard Deviation 10.432
|
16.07 mg/g
Standard Deviation 11.551
|
18.07 mg/g
Standard Deviation 14.909
|
1.80 mg/g
Standard Deviation 9.214
|
3.29 mg/g
Standard Deviation 8.011
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
16.62 mg/g
Standard Deviation 22.808
|
—
|
4.89 mg/g
Standard Deviation 20.082
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
|
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 1.870
|
—
|
7.41 mg/g
|
—
|
-2.11 mg/g
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
|
—
|
—
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|
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
|
—
|
8.81 mg/g
Standard Deviation 0.629
|
—
|
-0.28 mg/g
Standard Deviation 2.585
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
14.06 mg/g
Standard Deviation 8.973
|
16.60 mg/g
Standard Deviation 13.108
|
17.13 mg/g
Standard Deviation 11.092
|
2.59 mg/g
Standard Deviation 9.748
|
3.59 mg/g
Standard Deviation 6.886
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=80 Participants
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
|
Control (no VBM-FG2)
n=50 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=79 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=48 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=74 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=46 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
13.70 percent change from baseline
Standard Deviation 7.870
|
24.84 percent change from baseline
Standard Deviation 14.892
|
16.55 percent change from baseline
Standard Deviation 6.791
|
62.5 percent change from baseline
Standard Deviation 69.50
|
41.1 percent change from baseline
Standard Deviation 72.40
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
8.14 percent change from baseline
|
10.23 percent change from baseline
Standard Deviation 3.053
|
13.62 percent change from baseline
Standard Deviation 1.600
|
40.0 percent change from baseline
Standard Deviation 55.51
|
81.1 percent change from baseline
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
14.77 percent change from baseline
Standard Deviation 10.432
|
16.07 percent change from baseline
Standard Deviation 11.551
|
18.07 percent change from baseline
Standard Deviation 14.909
|
19.0 percent change from baseline
Standard Deviation 61.98
|
27.6 percent change from baseline
Standard Deviation 46.51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
16.62 percent change from baseline
Standard Deviation 22.808
|
—
|
15.1 percent change from baseline
Standard Deviation 93.59
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
|
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 1.870
|
—
|
7.41 percent change from baseline
|
—
|
-22.1 percent change from baseline
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
8.81 percent change from baseline
Standard Deviation 0.629
|
—
|
-0.1 percent change from baseline
Standard Deviation 28.42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
14.06 percent change from baseline
Standard Deviation 8.973
|
16.60 percent change from baseline
Standard Deviation 13.108
|
17.13 percent change from baseline
Standard Deviation 11.092
|
25.2 percent change from baseline
Standard Deviation 65.08
|
35.5 percent change from baseline
Standard Deviation 60.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=84 Participants
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
|
Control (no VBM-FG2)
n=54 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=83 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=52 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=81 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=51 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
4934.00 ng/g
Standard Deviation 4812.350
|
8389.80 ng/g
Standard Deviation 6625.523
|
6358.61 ng/g
Standard Deviation 5253.083
|
2410.02 ng/g
Standard Deviation 2986.346
|
1341.70 ng/g
Standard Deviation 2495.655
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
6930.38 ng/g
Standard Deviation 5483.666
|
4352.99 ng/g
Standard Deviation 3873.342
|
8688.22 ng/g
Standard Deviation 3272.243
|
136.06 ng/g
Standard Deviation 3959.381
|
1757.84 ng/g
Standard Deviation 2211.423
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5356.63 ng/g
Standard Deviation 5359.524
|
7335.57 ng/g
Standard Deviation 7068.643
|
6481.35 ng/g
Standard Deviation 6132.009
|
875.52 ng/g
Standard Deviation 4755.856
|
903.68 ng/g
Standard Deviation 3218.825
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
9795.94 ng/g
Standard Deviation 12602.08
|
—
|
1941.73 ng/g
Standard Deviation 11042.40
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
440.59 ng/g
Standard Deviation 225.383
|
—
|
-5069.60 ng/g
Standard Deviation 101.944
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
2896.76 ng/g
Standard Deviation 1518.588
|
—
|
203.64 ng/g
Standard Deviation 184.391
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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 5741.490
|
5195.78 ng/g
Standard Deviation 4999.201
|
7098.86 ng/g
Standard Deviation 7113.465
|
6502.50 ng/g
Standard Deviation 5540.461
|
903.49 ng/g
Standard Deviation 4985.072
|
1160.48 ng/g
Standard Deviation 2798.644
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=84 Participants
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
|
Control (no VBM-FG2)
n=54 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=83 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=52 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=81 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=51 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
4934.00 percent change from baseline
Standard Deviation 4812.350
|
8389.80 percent change from baseline
Standard Deviation 6625.523
|
6358.61 percent change from baseline
Standard Deviation 5253.083
|
50.0 percent change from baseline
Standard Deviation 58.51
|
46.5 percent change from baseline
Standard Deviation 76.26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
6930.38 percent change from baseline
Standard Deviation 5483.666
|
4352.99 percent change from baseline
Standard Deviation 3873.342
|
8688.22 percent change from baseline
Standard Deviation 3272.243
|
16.1 percent change from baseline
Standard Deviation 61.36
|
55.3 percent change from baseline
Standard Deviation 75.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5356.63 percent change from baseline
Standard Deviation 5359.524
|
7335.57 percent change from baseline
Standard Deviation 7068.643
|
6481.35 percent change from baseline
Standard Deviation 6132.009
|
19.9 percent change from baseline
Standard Deviation 76.46
|
29.4 percent change from baseline
Standard Deviation 66.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
9795.94 percent change from baseline
Standard Deviation 12602.08
|
—
|
30.3 percent change from baseline
Standard Deviation 123.78
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
440.59 percent change from baseline
Standard Deviation 225.383
|
—
|
-92.0 percent change from baseline
Standard Deviation 3.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
2896.76 percent change from baseline
Standard Deviation 1518.588
|
—
|
6.7 percent change from baseline
Standard Deviation 3.53
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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 5741.490
|
5195.78 percent change from baseline
Standard Deviation 4999.201
|
7098.86 percent change from baseline
Standard Deviation 7113.465
|
6502.50 percent change from baseline
Standard Deviation 5540.461
|
20.9 percent change from baseline
Standard Deviation 76.27
|
39.1 percent change from baseline
Standard Deviation 70.93
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
5.31 percent saturation of carboxyhemoglobin
Standard Deviation 1.627
|
5.97 percent saturation of carboxyhemoglobin
Standard Deviation 1.803
|
5.39 percent saturation of carboxyhemoglobin
Standard Deviation 1.786
|
-0.65 percent saturation of carboxyhemoglobin
Standard Deviation 1.099
|
0.09 percent saturation of carboxyhemoglobin
Standard Deviation 1.178
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
3.65 percent saturation of carboxyhemoglobin
Standard Deviation 2.192
|
5.00 percent saturation of carboxyhemoglobin
Standard Deviation 1.278
|
4.60 percent saturation of carboxyhemoglobin
Standard Deviation 1.414
|
-0.68 percent saturation of carboxyhemoglobin
Standard Deviation 1.342
|
0.95 percent saturation of carboxyhemoglobin
Standard Deviation 0.778
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
4.99 percent saturation of carboxyhemoglobin
Standard Deviation 2.184
|
5.11 percent saturation of carboxyhemoglobin
Standard Deviation 2.066
|
4.57 percent saturation of carboxyhemoglobin
Standard Deviation 1.847
|
-0.29 percent saturation of carboxyhemoglobin
Standard Deviation 1.323
|
-0.42 percent saturation of carboxyhemoglobin
Standard Deviation 0.986
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
3.21 percent saturation of carboxyhemoglobin
Standard Deviation 1.870
|
—
|
-2.15 percent saturation of carboxyhemoglobin
Standard Deviation 0.952
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
1.45 percent saturation of carboxyhemoglobin
Standard Deviation 0.212
|
—
|
-3.00 percent saturation of carboxyhemoglobin
Standard Deviation 0.141
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
3.65 percent saturation of carboxyhemoglobin
Standard Deviation 0.919
|
—
|
-0.60 percent saturation of carboxyhemoglobin
Standard Deviation 1.414
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5.11 percent saturation of carboxyhemoglobin
Standard Deviation 1.897
|
4.91 percent saturation of carboxyhemoglobin
Standard Deviation 2.071
|
5.00 percent saturation of carboxyhemoglobin
Standard Deviation 1.821
|
-0.61 percent saturation of carboxyhemoglobin
Standard Deviation 1.387
|
-0.10 percent saturation of carboxyhemoglobin
Standard Deviation 1.118
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=87 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
5.31 percent change from baseline
Standard Deviation 1.627
|
5.97 percent change from baseline
Standard Deviation 1.803
|
5.39 percent change from baseline
Standard Deviation 1.786
|
-7.6 percent change from baseline
Standard Deviation 17.41
|
3.6 percent change from baseline
Standard Deviation 27.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
3.65 percent change from baseline
Standard Deviation 2.192
|
5.00 percent change from baseline
Standard Deviation 1.278
|
4.60 percent change from baseline
Standard Deviation 1.414
|
-4.0 percent change from baseline
Standard Deviation 29.21
|
39.6 percent change from baseline
Standard Deviation 45.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
4.99 percent change from baseline
Standard Deviation 2.184
|
5.11 percent change from baseline
Standard Deviation 2.066
|
4.57 percent change from baseline
Standard Deviation 1.847
|
-3.7 percent change from baseline
Standard Deviation 25.91
|
-6.1 percent change from baseline
Standard Deviation 18.12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
3.21 percent change from baseline
Standard Deviation 1.870
|
—
|
-42.5 percent change from baseline
Standard Deviation 18.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
1.45 percent change from baseline
Standard Deviation 0.212
|
—
|
-67.5 percent change from baseline
Standard Deviation 2.19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
3.65 percent change from baseline
Standard Deviation 0.919
|
—
|
-5.9 percent change from baseline
Standard Deviation 30.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5.11 percent change from baseline
Standard Deviation 1.897
|
4.91 percent change from baseline
Standard Deviation 2.071
|
5.00 percent change from baseline
Standard Deviation 1.821
|
-9.3 percent change from baseline
Standard Deviation 27.89
|
0.7 percent change from baseline
Standard Deviation 25.53
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=88 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
20.59 ppm
Standard Deviation 9.109
|
25.91 ppm
Standard Deviation 8.860
|
20.21 ppm
Standard Deviation 9.537
|
-3.73 ppm
Standard Deviation 10.248
|
-0.38 ppm
Standard Deviation 7.894
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.50 ppm
Standard Deviation 10.607
|
21.50 ppm
Standard Deviation 9.957
|
18.50 ppm
Standard Deviation 2.121
|
-1.00 ppm
Standard Deviation 9.798
|
7.00 ppm
Standard Deviation 8.485
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
20.96 ppm
Standard Deviation 11.126
|
21.13 ppm
Standard Deviation 10.091
|
19.08 ppm
Standard Deviation 8.707
|
-0.46 ppm
Standard Deviation 8.466
|
-1.88 ppm
Standard Deviation 5.102
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
9.88 ppm
Standard Deviation 6.081
|
—
|
-10.75 ppm
Standard Deviation 8.172
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
4.00 ppm
Standard Deviation 2.828
|
—
|
-13.00 ppm
Standard Deviation 1.414
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
13.00 ppm
Standard Deviation 8.485
|
—
|
-5.50 ppm
Standard Deviation 7.778
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
20.42 ppm
Standard Deviation 10.046
|
20.15 ppm
Standard Deviation 10.410
|
19.65 ppm
Standard Deviation 8.939
|
-2.28 ppm
Standard Deviation 9.175
|
-0.76 ppm
Standard Deviation 6.899
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=88 Participants
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
|
Control (no VBM-FG2)
n=55 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
n=87 Participants
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
n=55 Participants
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
20.42 percent change from baseline
Standard Deviation 10.046
|
20.15 percent change from baseline
Standard Deviation 10.410
|
19.65 percent change from baseline
Standard Deviation 8.939
|
-3.1 percent change from baseline
Standard Deviation 47.00
|
9.0 percent change from baseline
Standard Deviation 66.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
20.59 percent change from baseline
Standard Deviation 9.109
|
25.91 percent change from baseline
Standard Deviation 8.860
|
20.21 percent change from baseline
Standard Deviation 9.537
|
-7.0 percent change from baseline
Standard Deviation 32.63
|
6.8 percent change from baseline
Standard Deviation 58.17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.50 percent change from baseline
Standard Deviation 10.607
|
21.50 percent change from baseline
Standard Deviation 9.957
|
18.50 percent change from baseline
Standard Deviation 2.121
|
6.6 percent change from baseline
Standard Deviation 45.21
|
165.1 percent change from baseline
Standard Deviation 226.09
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
20.96 percent change from baseline
Standard Deviation 11.126
|
21.13 percent change from baseline
Standard Deviation 10.091
|
19.08 percent change from baseline
Standard Deviation 8.707
|
6.0 percent change from baseline
Standard Deviation 47.63
|
-1.4 percent change from baseline
Standard Deviation 40.74
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
9.88 percent change from baseline
Standard Deviation 6.081
|
—
|
-49.2 percent change from baseline
Standard Deviation 27.25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
4.00 percent change from baseline
Standard Deviation 2.828
|
—
|
-77.9 percent change from baseline
Standard Deviation 11.11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
13.00 percent change from baseline
Standard Deviation 8.485
|
—
|
-18.3 percent change from baseline
Standard Deviation 25.93
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)Population: Per-protocol
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.
Outcome measures
| Measure |
Test (ad Libitum VBM-FG2)
n=84 Participants
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
|
Control (no VBM-FG2)
n=54 Participants
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
Test (Visit 5)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 5
|
Control (Visit 5)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5
|
Test (Visit 6)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to Visit 6
|
Control (Visit 6)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6
|
Test (End of Study)
Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) cigarette consumption from Baseline to End of Study
|
Control (End of Study)
Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study
|
Test (Visit 6)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Visit 6
|
Control (Visit 6)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6
|
Test (End of Study)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) End of Study
|
Control (End of Study)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study
|
Test (Day 7)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 7
|
Control (Day 7)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7
|
Test (Day 8)
Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \[VBM-FG2 oral discs\]) Day 8
|
Control (Day 8)
Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Characterization of Subgroups Based on Change From Baseline in Total NNAL
Increase
|
46 Participants
|
36 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Characterization of Subgroups Based on Change From Baseline in Total NNAL
Reduction
|
38 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Test (ad Libitum VBM-FG2)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Control (no VBM-FG2)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test (ad Libitum VBM-FG2)
n=92 participants at risk
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
|
Control (no VBM-FG2)
n=62 participants at risk
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
6/92 • Number of events 6 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
3.2%
2/62 • Number of events 2 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.3%
3/92 • Number of events 3 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
3.2%
2/62 • Number of events 2 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.3%
4/92 • Number of events 4 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
1.6%
1/62 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
2.2%
2/92 • Number of events 2 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
2.2%
2/92 • Number of events 2 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/92 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
1.6%
1/62 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
General disorders
Fatigue
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
3.2%
2/62 • Number of events 2 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
General disorders
Asthenia
|
0.00%
0/92 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
1.6%
1/62 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
General disorders
Oedema peripheral
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
General disorders
Pyrexia
|
0.00%
0/92 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
1.6%
1/62 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Infections and infestations
Oral herpes
|
2.2%
2/92 • Number of events 2 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
2/92 • Number of events 2 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Infections and infestations
Fungal infection
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Infections and infestations
Urogenital trichomoniasis
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
1.6%
1/62 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/92 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
1.6%
1/62 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Nervous system disorders
Headache
|
3.3%
3/92 • Number of events 3 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
3.2%
2/62 • Number of events 2 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
2/92 • Number of events 2 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
1.6%
1/62 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/92 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
1.6%
1/62 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.00%
0/92 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
1.6%
1/62 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Renal and urinary disorders
Bladder discomfort
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Renal and urinary disorders
Dysuria
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
0.00%
0/62 • Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
|
Additional Information
Jeffery Edmiston, Functional Director Clinical Research
Altria
Phone: 8043352366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place