Tobacco Dependence
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of a novel nicotine product for continuous abstinence from smoking. Efficacy of product will be evaluated by assessments of self-reported abstinence, verified by exhaled carbon monoxide (CO) levels.
Interventions
DRUGNicotine Spray
Nicotine Spray
DRUGPlacebo
Placebo to match nicotine spray
Sponsors
GlaxoSmithKline
McNeil AB
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking
Exclusion criteria
History of cardiovascular disease, stomach ulcer or diabetes unless physician's written approval is obtained. Use of other forms of tobacco/nicotine containing products other than cigarettes within 30 days before baseline visit. Use of nicotine replacement therapies or other smoking cessation medicines/non-drug therapies within 30 days before the baseline visit. Pregnancy or intending to become pregnant. Hypersensitivity to the product, history of alcohol or substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6 | Week 2 to Week 6 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 19 | Week 19 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 7 | Week 7 | Total Daily Number of Self-Reported Spray Doses |
| Number of Cigarettes Smoked Per Day at Week 26 | Week 26 | Number of Cigarettes Smoked Per Day |
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12 | Week 2 to Week 12 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking |
| Total Daily Number of Self-Reported Spray Doses at Week 8 | Week 8 | Total Daily Number of Self-Reported Spray Doses |
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26 | Week 2 to Week 26 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking |
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4 | Week 2 to Week 4 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking |
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8 | Week 2 to Week 8 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking |
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16 | Week 2 to Week 16 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking |
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20 | Week 2 to Week 20 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking |
| Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 | Week 1 | Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2 | Week 2 | Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4 | Week 4 | Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6 | Week 6 | Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1 | Week 1 | Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2 | Week 2 | Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4 | Week 4 | Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6 | Week 6 | Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1 | Week 1 | Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2 | Week 2 | Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4 | Week 4 | Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6 | Week 6 | Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1 | Week 1 | Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2 | Week 2 | Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4 | Week 4 | Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6 | Week 6 | Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1 | Week 1 | Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2 | Week 2 | Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4 | Week 4 | Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6 | Week 6 | Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1 | Week 1 | Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2 | Week 2 | Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4 | Week 4 | Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6 | Week 6 | Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1 | Week 1 | Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2 | Week 2 | Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4 | Week 4 | Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6 | Week 6 | Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1 | Week 1 | Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2 | Week 2 | Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4 | Week 4 | Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6 | Week 6 | Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Aggregated Withdrawal Score at Week 1 | Week 1 | Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28. |
| Aggregated Withdrawal Score at Week 2 | Week 2 | Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28. |
| Aggregated Withdrawal Score at Week 4 | Week 4 | Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28. |
| Aggregated Withdrawal Score at Week 6 | Week 6 | Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28. |
| Total Daily Number of Self-Reported Spray Doses at Week 1 | Week 1 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 2 | Week 2 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 3 | Week 3 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 4 | Week 4 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 5 | Week 5 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 6 | Week 6 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 9 | Week 9 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 10 | Week 10 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 11 | Week 11 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 12 | Week 12 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 13 | Week 13 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 14 | Week 14 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 15 | Week 15 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 16 | Week 16 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 17 | Week 17 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 18 | Week 18 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 19 | Week 19 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 20 | Week 20 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 21 | Week 21 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 22 | Week 22 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 23 | Week 23 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 24 | Week 24 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 25 | Week 25 | Total Daily Number of Self-Reported Spray Doses |
| Total Daily Number of Self-Reported Spray Doses at Week 26 | Week 26 | Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 1 | Week 1 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 2 | Week 2 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 3 | Week 3 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 4 | Week 4 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 5 | Week 5 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 6 | Week 6 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 7 | Week 7 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 8 | Week 8 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 9 | Week 9 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 10 | Week 10 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 11 | Week 11 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 12 | Week 12 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 13 | Week 13 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 14 | Week 14 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 15 | Week 15 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 16 | Week 16 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 17 | Week 17 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 20 | Week 20 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 21 | Week 21 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 22 | Week 22 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 23 | Week 23 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 24 | Week 24 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 25 | Week 25 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 26 | Week 26 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 1 | Week 1 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 2 | Week 2 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 3 | Week 3 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 4 | Week 4 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 5 | Week 5 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 6 | Week 6 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 7 | Week 7 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 8 | Week 8 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 9 | Week 9 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 10 | Week 10 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 11 | Week 11 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 12 | Week 12 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 13 | Week 13 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 14 | Week 14 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 15 | Week 15 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 16 | Week 16 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 17 | Week 17 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 18 | Week 18 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 19 | Week 19 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 20 | Week 20 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 21 | Week 21 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 22 | Week 22 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 23 | Week 23 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 24 | Week 24 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 25 | Week 25 | Maximum Hourly Number of Self-Reported Spray Doses |
| Maximum Hourly Number of Self-Reported Spray Doses at Week 26 | Week 26 | Maximum Hourly Number of Self-Reported Spray Doses |
| Number of Cigarettes Smoked Since Last Visit at Week 1 | Week 1 | Number of Cigarettes Smoked Since Last Visit |
| Number of Cigarettes Smoked Since Last Visit at Week 2 | Week 2 | Number of Cigarettes Smoked Since Last Visit |
| Number of Cigarettes Smoked Per Day at Week 4 | Week 4 | Number of Cigarettes Smoked Per Day |
| Number of Cigarettes Smoked Per Day at Week 6 | Week 6 | Number of Cigarettes Smoked Per Day |
| Number of Cigarettes Smoked Per Day at Week 8 | Week 8 | Number of Cigarettes Smoked Per Day |
| Number of Cigarettes Smoked Per Day at Week 12 | Week 12 | Number of Cigarettes Smoked Per Day |
| Number of Cigarettes Smoked Per Day at Week 16 | Week 16 | Number of Cigarettes Smoked Per Day |
| Number of Cigarettes Smoked Per Day at Week 20 | Week 20 | Number of Cigarettes Smoked Per Day |
| Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | Week 1 | Participants were asked to rate the investigational product on a 10-point scale of 1 - 10 (where 1=very poor and 10=excellent). |
| Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | Week 6 | Participants were asked to rate the investigational product on a 10-point scale of 1 - 10 (where 1=very poor and 10=excellent). |
| Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | Week 12 | Participants were asked to rate the investigational product on a 10-point scale of 1 - 10 (where 1=very poor and 10=excellent). |
| Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1 | Week 1 | Participants were asked to rate the product in its effectiveness for dealing with desire/urge to smoke on a 5-point scale of 1 - 5 (where 1=not all effective and 5=extremely effective). |
| Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6 | Week 6 | Participants were asked to rate the product in its effectiveness for dealing with desire/urge to smoke on a 5-point scale of 1 - 5 (where 1=not all effective and 5=extremely effective). |
| Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12 | Week 12 | Participants were asked to rate the product in its effectiveness for dealing with desire/urge to smoke on a 5-point scale of 1 - 5 (where 1=not all effective and 5=extremely effective). |
| Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Week 1 | Participants were asked to rate the speed of action of the product on a 9-point scale of 1 - 9 (where 1=extremely slow and 9=extremely fast). |
| Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Week 6 | Participants were asked to rate the speed of action of the product on a 9-point scale of 1 - 9 (where 1=extremely slow and 9=extremely fast). |
| Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Week 12 | Participants were asked to rate the speed of action of the product on a 9-point scale of 1 - 9 (where 1=extremely slow and 9=extremely fast). |
| Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product | Week 1 | Participants were asked to rate their change of opinion concerning product compared to when first used product on a 5-point scale of 1 - 5 (where 1=I like it much less now and 5=I like it much more now). |
| Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product | Week 6 | Participants were asked to rate their change of opinion concerning product compared to when first used product on a 5-point scale of 1 - 5 (where 1=I like it much less now and 5=I like it much more now). |
| Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product | Week 12 | Participants were asked to rate their change of opinion concerning product compared to when first used product on a 5-point scale of 1 - 5 (where 1=I like it much less now and 5=I like it much more now). |
| Percentage Distribution of the Participant Score for Product Convenience at Week 1 | Week 1 | Participants were asked to rate the product convenience on a 5-point scale of 1 - 5 (where 1=not at all convenient and 5=extremely convenient). |
| Percentage Distribution of the Participant Score for Product Convenience at Week 6 | Week 6 | Participants were asked to rate the product convenience on a 5-point scale of 1 - 5 (where 1=not at all convenient and 5=extremely convenient). |
| Percentage Distribution of the Participant Score for Product Convenience at Week 12 | Week 12 | Participants were asked to rate the product convenience on a 5-point scale of 1 - 5 (where 1=not at all convenient and 5=extremely convenient). |
| Systolic Blood Pressure at Week 1 | Week 1 | Systolic blood pressure (mm Hg) |
| Systolic Blood Pressure at Week 2 | Week 2 | Systolic blood pressure (mm Hg) |
| Systolic Blood Pressure at Week 4 | Week 4 | Systolic blood pressure (mm Hg) |
| Systolic Blood Pressure at Week 6 | Week 6 | Systolic blood pressure (mm Hg) |
| Systolic Blood Pressure at Week 8 | Week 8 | Systolic blood pressure (mm Hg) |
| Systolic Blood Pressure at Week 12 | Week 12 | Systolic blood pressure (mm Hg) |
| Systolic Blood Pressure at Week 16 | Week 16 | Systolic blood pressure (mm Hg) |
| Systolic Blood Pressure at Week 20 | Week 20 | Systolic blood pressure (mm Hg) |
| Systolic Blood Pressure at Week 26 | Week 26 | Systolic blood pressure (mm Hg) |
| Change From Baseline in Systolic Blood Pressure at Week 1 | Baseline to Week 1 | Change from baseline in systolic blood pressure (mm Hg) |
| Change From Baseline in Systolic Blood Pressure at Week 2 | Baseline to Week 2 | Change from baseline in systolic blood pressure (mm Hg) |
| Change From Baseline in Systolic Blood Pressure at Week 4 | Baseline to Week 4 | Change from baseline in systolic blood pressure (mm Hg) |
| Change From Baseline in Systolic Blood Pressure at Week 6 | Baseline to Week 6 | Change from baseline in systolic blood pressure (mm Hg) |
| Change From Baseline in Systolic Blood Pressure at Week 8 | Baseline to Week 8 | Change from baseline in systolic blood pressure (mm Hg) |
| Change From Baseline in Systolic Blood Pressure at Week 12 | Baseline to Week 12 | Change from baseline in systolic blood pressure (mm Hg) |
| Change From Baseline in Systolic Blood Pressure at Week 16 | Baseline to Week 16 | Change from baseline in systolic blood pressure (mm Hg) |
| Change From Baseline in Systolic Blood Pressure at Week 20 | Baseline to Week 20 | Change from baseline in systolic blood pressure (mm Hg) |
| Change From Baseline in Systolic Blood Pressure at Week 26 | Baseline to Week 26 | Change from baseline in systolic blood pressure (mm Hg) |
| Diastolic Blood Pressure at Week 1 | Week 1 | Diastolic blood pressure (mm Hg) |
| Diastolic Blood Pressure at Week 2 | Week 2 | Diastolic blood pressure (mm Hg) |
| Diastolic Blood Pressure at Week 4 | Week 4 | Diastolic blood pressure (mm Hg) |
| Diastolic Blood Pressure at Week 6 | Week 6 | Diastolic blood pressure (mm Hg) |
| Diastolic Blood Pressure at Week 8 | Week 8 | Diastolic blood pressure (mm Hg) |
| Diastolic Blood Pressure at Week 12 | Week 12 | Diastolic blood pressure (mm Hg) |
| Diastolic Blood Pressure at Week 16 | Week 16 | Diastolic blood pressure (mm Hg) |
| Diastolic Blood Pressure at Week 20 | Week 20 | Diastolic blood pressure (mm Hg) |
| Diastolic Blood Pressure at Week 26 | Week 26 | Diastolic blood pressure (mm Hg) |
| Change From Baseline in Diastolic Blood Pressure at Week 1 | Baseline to Week 1 | Change from baseline in diastolic blood pressure (mm Hg) |
| Change From Baseline in Diastolic Blood Pressure at Week 2 | Baseline to Week 2 | Change from baseline in diastolic blood pressure (mm Hg) |
| Change From Baseline in Diastolic Blood Pressure at Week 4 | Baseline to Week 4 | Change from baseline in diastolic blood pressure (mm Hg) |
| Change From Baseline in Diastolic Blood Pressure at Week 6 | Baseline to Week 6 | Change from baseline in diastolic blood pressure (mm Hg) |
| Change From Baseline in Diastolic Blood Pressure at Week 8 | Baseline to Week 8 | Change from baseline in diastolic blood pressure (mm Hg) |
| Change From Baseline in Diastolic Blood Pressure at Week 12 | Baseline to Week 12 | Change from baseline in diastolic blood pressure (mm Hg) |
| Change From Baseline in Diastolic Blood Pressure at Week 16 | Baseline to Week 16 | Change from baseline in diastolic blood pressure (mm Hg) |
| Change From Baseline in Diastolic Blood Pressure at Week 20 | Baseline to Week 20 | Change from baseline in diastolic blood pressure (mm Hg) |
| Change From Baseline in Diastolic Blood Pressure at Week 26 | Baseline to Week 26 | Change from baseline in diastolic blood pressure (mm Hg) |
| Pulse at Week 1 | Week 1 | Pulse (beats per minute) |
| Pulse at Week 2 | Week 2 | Pulse (beats per minute) |
| Pulse at Week 4 | Week 4 | Pulse (beats per minute) |
| Pulse at Week 6 | Week 6 | Pulse (beats per minute) |
| Pulse at Week 8 | Week 8 | Pulse (beats per minute) |
| Pulse at Week 12 | Week 12 | Pulse (beats per minute) |
| Pulse at Week 16 | Week 16 | Pulse (beats per minute) |
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 18 | Week 18 | Maximum Total Daily Number of Self-Reported Spray Doses |
| Pulse at Week 26 | Week 26 | Pulse (beats per minute) |
| Change From Baseline in Pulse at Week 1 | Baseline to Week 1 | Change from baseline in pulse (beats per minute) |
| Change From Baseline in Pulse at Week 2 | Baseline to Week 2 | Change from baseline in pulse (beats per minute) |
| Change From Baseline in Pulse at Week 4 | Baseline to Week 4 | Change from baseline in pulse (beats per minute) |
| Change From Baseline in Pulse at Week 6 | Baseline to Week 6 | Change from baseline in pulse (beats per minute) |
| Change From Baseline in Pulse at Week 8 | Baseline to Week 8 | Change from baseline in pulse (beats per minute) |
| Change From Baseline in Pulse at Week 12 | Baseline to Week 12 | Change from baseline in pulse (beats per minute) |
| Change From Baseline in Pulse at Week 16 | Baseline to Week 16 | Change from baseline in pulse (beats per minute) |
| Change From Baseline in Pulse at Week 20 | Baseline to Week 20 | Change from baseline in pulse (beats per minute) |
| Change From Baseline in Pulse at Week 26 | Baseline to Week 26 | Change from baseline in pulse (beats per minute) |
| Percentage of Participants With New or Worsened Conditions in Lips/Labial Mucosa at Week 6 or When Withdrawn From Study | Week 6 or when withdrawn from study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. |
| Percentage of Participants With New or Worsened Conditions in Buccal Mucosa at Week 6 or When Withdrawn From Study | Week 6 or when withdrawn from study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. |
| Percentage of Participants With New or Worsened Conditions in Mucobuccal Fold at Week 6 or When Withdrawn From Study | Week 6 or when withdrawn from study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. |
| Percentage of Participants With New or Worsened Conditions in Sublingual Mucosa at Week 6 or When Withdrawn From Study | Week 6 or when withdrawn from study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. |
| Percentage of Participants With New or Worsened Conditions in Gingiva at Week 6 or When Withdrawn From Study | Week 6 or when withdrawn from study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. |
| Percentage of Participants With New or Worsened Conditions in Tongue at Week 6 or When Withdrawn From Study | Week 6 or when withdrawn from study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. |
| Percentage of Participants With New or Worsened Conditions in Hard/Soft Palate at Week 6 or When Withdrawn From Study | Week 6 or when withdrawn from study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. |
| Percentage of Participants With New or Worsened Conditions in Uvula/Oropharynx at Week 6 or When Withdrawn From Study | Week 6 or when withdrawn from study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. |
| Percentage of Participants With New or Worsened Conditions in Visual Mouth Inspection Overall at Week 6 or When Withdrawn From Study | Week 6 or when withdrawn from study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. |
| Change From Baseline in Body Weight at Week 6 | Baseline to Week 6 | Change from baseline in body weight |
| Change From Baseline in Body Weight at Week 12 | Baseline to Week 12 | Change from baseline in body weight |
| Change From Baseline in Body Weight at Week 26 | Baseline to Week 26 | Change from baseline in body weight |
| Change From Baseline in Body Weight at Week 6 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit | Baseline to Week 6 | Change from baseline in body weight |
| Change From Baseline in Body Weight at Week 12 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit | Baseline to Week 12 | Change from baseline in body weight |
| Change From Baseline in Body Weight at Week 26 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit | Baseline to Week 26 | Change from baseline in body weight |
| Pulse at Week 20 | Week 20 | Pulse (beats per minute) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | 601 |
| Nicotine Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions | 597 |
| Total | 1,198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 16 | 24 |
| Overall Study | Compliance, PI decision, move, eligible | 6 | 3 |
| Overall Study | Death | 4 | 2 |
| Overall Study | Lost to Follow-up | 131 | 103 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 90 | 100 |
Baseline characteristics
| Characteristic | Placebo | Nicotine | Total |
|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 11.72 | 51.5 years STANDARD_DEVIATION 11.7 | 51.3 years STANDARD_DEVIATION 11.71 |
| Region of Enrollment United States USA | 601 Participants | 597 Participants | 1198 Participants |
| Sex: Female, Male Female | 319 Participants | 332 Participants | 651 Participants |
| Sex: Female, Male Male | 282 Participants | 265 Participants | 547 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 140 / 601 | 349 / 597 |
| serious Total, serious adverse events | 14 / 601 | 20 / 597 |
Outcome results
Primary
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Time frame: Week 2 to Week 6
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6 | 2.5 Percentage of Participants |
| Nicotine | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6 | 5.0 Percentage of Participants |
Comparison: The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.p-value: 0.02195% CI: [1.1, 3.66]Cochran-Mantel-Haenszel
Secondary
Aggregated Withdrawal Score at Week 1
Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28.
Time frame: Week 1
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Aggregated Withdrawal Score at Week 1 | 5.1 units on a scale | Standard Deviation 4.25 |
| Nicotine | Aggregated Withdrawal Score at Week 1 | 4.5 units on a scale | Standard Deviation 4.2 |
Comparison: The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.p-value: 0.48395% CI: [-2.84, 1.73]Wilcoxon (Mann-Whitney)
Secondary
Aggregated Withdrawal Score at Week 2
Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28.
Time frame: Week 2
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Aggregated Withdrawal Score at Week 2 | 6.3 units on a scale | Standard Deviation 5.46 |
| Nicotine | Aggregated Withdrawal Score at Week 2 | 4.5 units on a scale | Standard Deviation 5.02 |
Comparison: The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.p-value: 0.10295% CI: [-4.24, 0.67]Wilcoxon (Mann-Whitney)
Secondary
Aggregated Withdrawal Score at Week 4
Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28.
Time frame: Week 4
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Aggregated Withdrawal Score at Week 4 | 4.2 units on a scale | Standard Deviation 3.53 |
| Nicotine | Aggregated Withdrawal Score at Week 4 | 3.7 units on a scale | Standard Deviation 3.77 |
Comparison: The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.p-value: 0.53295% CI: [-2.27, 1.38]Wilcoxon (Mann-Whitney)
Secondary
Aggregated Withdrawal Score at Week 6
Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28.
Time frame: Week 6
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Aggregated Withdrawal Score at Week 6 | 4.8 units on a scale | Standard Deviation 5.11 |
| Nicotine | Aggregated Withdrawal Score at Week 6 | 3.8 units on a scale | Standard Deviation 3.8 |
Comparison: The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.p-value: 0.35495% CI: [-2.93, 0.91]Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Body Weight at Week 12
Change from baseline in body weight
Time frame: Baseline to Week 12
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Body Weight at Week 12 | -0.3 pounds | Standard Deviation 7.4 |
| Nicotine | Change From Baseline in Body Weight at Week 12 | 0.4 pounds | Standard Deviation 6.89 |
Secondary
Change From Baseline in Body Weight at Week 12 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit
Change from baseline in body weight
Time frame: Baseline to Week 12
Population: Analysis was based on randomized participants verified continuously abstinent from smoking since the Week 2 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Body Weight at Week 12 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit | 4.2 pounds | Standard Deviation 8.89 |
| Nicotine | Change From Baseline in Body Weight at Week 12 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit | 6.4 pounds | Standard Deviation 6.92 |
Comparison: The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.p-value: 0.38395% CI: [-4.03, 10.11]ANCOVA
Secondary
Change From Baseline in Body Weight at Week 26
Change from baseline in body weight
Time frame: Baseline to Week 26
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Body Weight at Week 26 | -0.2 pounds | Standard Deviation 11.07 |
| Nicotine | Change From Baseline in Body Weight at Week 26 | 1.0 pounds | Standard Deviation 8.43 |
Secondary
Change From Baseline in Body Weight at Week 26 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit
Change from baseline in body weight
Time frame: Baseline to Week 26
Population: Analysis was based on randomized participants verified continuously abstinent from smoking since the Week 2 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Body Weight at Week 26 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit | 2.5 pounds | Standard Deviation 5.67 |
| Nicotine | Change From Baseline in Body Weight at Week 26 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit | 9.3 pounds | Standard Deviation 9.52 |
Comparison: The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.p-value: 0.13895% CI: [-2.56, 16.83]ANCOVA
Secondary
Change From Baseline in Body Weight at Week 6
Change from baseline in body weight
Time frame: Baseline to Week 6
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Body Weight at Week 6 | 0.5 pounds | Standard Deviation 5.73 |
| Nicotine | Change From Baseline in Body Weight at Week 6 | 0.7 pounds | Standard Deviation 6.29 |
Secondary
Change From Baseline in Body Weight at Week 6 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit
Change from baseline in body weight
Time frame: Baseline to Week 6
Population: Analysis was based on randomized participants verified continuously abstinent from smoking since the Week 2 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Body Weight at Week 6 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit | 3.6 pounds | Standard Deviation 5.93 |
| Nicotine | Change From Baseline in Body Weight at Week 6 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit | 3.7 pounds | Standard Deviation 5.79 |
Comparison: The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.p-value: 0.55895% CI: [-2.42, 4.41]ANCOVA
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 1
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 1
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Week 1 | 0.1 mm Hg | Standard Deviation 8.98 |
| Nicotine | Change From Baseline in Diastolic Blood Pressure at Week 1 | 0.5 mm Hg | Standard Deviation 9.13 |
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 12
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 12
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Week 12 | -0.4 mm Hg | Standard Deviation 10.06 |
| Nicotine | Change From Baseline in Diastolic Blood Pressure at Week 12 | -0.4 mm Hg | Standard Deviation 10.28 |
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 16
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 16
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Week 16 | -0.6 mm Hg | Standard Deviation 10.19 |
| Nicotine | Change From Baseline in Diastolic Blood Pressure at Week 16 | -0.8 mm Hg | Standard Deviation 9.86 |
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 2
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 2
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Week 2 | -0.4 mm Hg | Standard Deviation 9.05 |
| Nicotine | Change From Baseline in Diastolic Blood Pressure at Week 2 | 0.4 mm Hg | Standard Deviation 9.27 |
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 20
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 20
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Week 20 | -0.8 mm Hg | Standard Deviation 10.07 |
| Nicotine | Change From Baseline in Diastolic Blood Pressure at Week 20 | -0.5 mm Hg | Standard Deviation 10.69 |
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 26
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 26
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Week 26 | -0.1 mm Hg | Standard Deviation 10.13 |
| Nicotine | Change From Baseline in Diastolic Blood Pressure at Week 26 | 0.7 mm Hg | Standard Deviation 10.71 |
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 4
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 4
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Week 4 | -0.3 mm Hg | Standard Deviation 9.58 |
| Nicotine | Change From Baseline in Diastolic Blood Pressure at Week 4 | -0.1 mm Hg | Standard Deviation 9.38 |
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 6
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 6
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Week 6 | -0.6 mm Hg | Standard Deviation 9.87 |
| Nicotine | Change From Baseline in Diastolic Blood Pressure at Week 6 | -1.0 mm Hg | Standard Deviation 9.37 |
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 8
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 8
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Week 8 | -0.4 mm Hg | Standard Deviation 10.1 |
| Nicotine | Change From Baseline in Diastolic Blood Pressure at Week 8 | -0.1 mm Hg | Standard Deviation 10.39 |
Secondary
Change From Baseline in Pulse at Week 1
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 1
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse at Week 1 | 1.4 beats per minute | Standard Deviation 10.69 |
| Nicotine | Change From Baseline in Pulse at Week 1 | 2.0 beats per minute | Standard Deviation 10.8 |
Secondary
Change From Baseline in Pulse at Week 12
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 12
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse at Week 12 | 0.9 beats per minute | Standard Deviation 11.09 |
| Nicotine | Change From Baseline in Pulse at Week 12 | 1.8 beats per minute | Standard Deviation 10.84 |
Secondary
Change From Baseline in Pulse at Week 16
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 16
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse at Week 16 | 2.8 beats per minute | Standard Deviation 11.58 |
| Nicotine | Change From Baseline in Pulse at Week 16 | 1.9 beats per minute | Standard Deviation 11.5 |
Secondary
Change From Baseline in Pulse at Week 2
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 2
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse at Week 2 | 1.2 beats per minute | Standard Deviation 10.75 |
| Nicotine | Change From Baseline in Pulse at Week 2 | 1.8 beats per minute | Standard Deviation 10.95 |
Secondary
Change From Baseline in Pulse at Week 20
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 20
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse at Week 20 | 2.7 beats per minute | Standard Deviation 11.25 |
| Nicotine | Change From Baseline in Pulse at Week 20 | 2.0 beats per minute | Standard Deviation 10.96 |
Secondary
Change From Baseline in Pulse at Week 26
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 26
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse at Week 26 | 3.2 beats per minute | Standard Deviation 11.16 |
| Nicotine | Change From Baseline in Pulse at Week 26 | 1.8 beats per minute | Standard Deviation 11.29 |
Secondary
Change From Baseline in Pulse at Week 4
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 4
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse at Week 4 | 1.3 beats per minute | Standard Deviation 11.42 |
| Nicotine | Change From Baseline in Pulse at Week 4 | 2.4 beats per minute | Standard Deviation 11.51 |
Secondary
Change From Baseline in Pulse at Week 6
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 6
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse at Week 6 | 1.0 beats per minute | Standard Deviation 11.23 |
| Nicotine | Change From Baseline in Pulse at Week 6 | 0.7 beats per minute | Standard Deviation 11.44 |
Secondary
Change From Baseline in Pulse at Week 8
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 8
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse at Week 8 | 1.2 beats per minute | Standard Deviation 11.51 |
| Nicotine | Change From Baseline in Pulse at Week 8 | 2.7 beats per minute | Standard Deviation 11.96 |
Secondary
Change From Baseline in Systolic Blood Pressure at Week 1
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 1
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Week 1 | -0.2 mm Hg | Standard Deviation 13.49 |
| Nicotine | Change From Baseline in Systolic Blood Pressure at Week 1 | 0.2 mm Hg | Standard Deviation 13.94 |
Secondary
Change From Baseline in Systolic Blood Pressure at Week 12
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 12
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Week 12 | -2.2 mm Hg | Standard Deviation 15.75 |
| Nicotine | Change From Baseline in Systolic Blood Pressure at Week 12 | -2.4 mm Hg | Standard Deviation 15.01 |
Secondary
Change From Baseline in Systolic Blood Pressure at Week 16
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 16
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Week 16 | -1.8 mm Hg | Standard Deviation 14.95 |
| Nicotine | Change From Baseline in Systolic Blood Pressure at Week 16 | -2.8 mm Hg | Standard Deviation 15.57 |
Secondary
Change From Baseline in Systolic Blood Pressure at Week 2
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 2
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Week 2 | -0.7 mm Hg | Standard Deviation 14.06 |
| Nicotine | Change From Baseline in Systolic Blood Pressure at Week 2 | -0.7 mm Hg | Standard Deviation 13.43 |
Secondary
Change From Baseline in Systolic Blood Pressure at Week 20
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 20
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Week 20 | -1.7 mm Hg | Standard Deviation 15.15 |
| Nicotine | Change From Baseline in Systolic Blood Pressure at Week 20 | -2.0 mm Hg | Standard Deviation 16.18 |
Secondary
Change From Baseline in Systolic Blood Pressure at Week 26
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 26
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Week 26 | -0.6 mm Hg | Standard Deviation 14.61 |
| Nicotine | Change From Baseline in Systolic Blood Pressure at Week 26 | -0.6 mm Hg | Standard Deviation 15.37 |
Secondary
Change From Baseline in Systolic Blood Pressure at Week 4
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 4
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Week 4 | -1.8 mm Hg | Standard Deviation 14.59 |
| Nicotine | Change From Baseline in Systolic Blood Pressure at Week 4 | -1.9 mm Hg | Standard Deviation 14.52 |
Secondary
Change From Baseline in Systolic Blood Pressure at Week 6
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 6
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Week 6 | -2.0 mm Hg | Standard Deviation 14.8 |
| Nicotine | Change From Baseline in Systolic Blood Pressure at Week 6 | -2.2 mm Hg | Standard Deviation 13.9 |
Secondary
Change From Baseline in Systolic Blood Pressure at Week 8
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 8
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Week 8 | -1.8 mm Hg | Standard Deviation 15.26 |
| Nicotine | Change From Baseline in Systolic Blood Pressure at Week 8 | -2.2 mm Hg | Standard Deviation 14.61 |
Secondary
Diastolic Blood Pressure at Week 1
Diastolic blood pressure (mm Hg)
Time frame: Week 1
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Diastolic Blood Pressure at Week 1 | 77.3 mm Hg | Standard Deviation 9.54 |
| Nicotine | Diastolic Blood Pressure at Week 1 | 78.0 mm Hg | Standard Deviation 9.99 |
Secondary
Diastolic Blood Pressure at Week 12
Diastolic blood pressure (mm Hg)
Time frame: Week 12
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Diastolic Blood Pressure at Week 12 | 76.6 mm Hg | Standard Deviation 10.12 |
| Nicotine | Diastolic Blood Pressure at Week 12 | 77.4 mm Hg | Standard Deviation 10.25 |
Secondary
Diastolic Blood Pressure at Week 16
Diastolic blood pressure (mm Hg)
Time frame: Week 16
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Diastolic Blood Pressure at Week 16 | 76.4 mm Hg | Standard Deviation 9.43 |
| Nicotine | Diastolic Blood Pressure at Week 16 | 77.0 mm Hg | Standard Deviation 10.1 |
Secondary
Diastolic Blood Pressure at Week 2
Diastolic blood pressure (mm Hg)
Time frame: Week 2
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Diastolic Blood Pressure at Week 2 | 76.7 mm Hg | Standard Deviation 9.72 |
| Nicotine | Diastolic Blood Pressure at Week 2 | 78.0 mm Hg | Standard Deviation 10.03 |
Secondary
Diastolic Blood Pressure at Week 20
Diastolic blood pressure (mm Hg)
Time frame: Week 20
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Diastolic Blood Pressure at Week 20 | 76.3 mm Hg | Standard Deviation 9.91 |
| Nicotine | Diastolic Blood Pressure at Week 20 | 76.8 mm Hg | Standard Deviation 10.5 |
Secondary
Diastolic Blood Pressure at Week 26
Diastolic blood pressure (mm Hg)
Time frame: Week 26
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Diastolic Blood Pressure at Week 26 | 76.9 mm Hg | Standard Deviation 9.21 |
| Nicotine | Diastolic Blood Pressure at Week 26 | 78.1 mm Hg | Standard Deviation 10.13 |
Secondary
Diastolic Blood Pressure at Week 4
Diastolic blood pressure (mm Hg)
Time frame: Week 4
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Diastolic Blood Pressure at Week 4 | 76.9 mm Hg | Standard Deviation 9.58 |
| Nicotine | Diastolic Blood Pressure at Week 4 | 77.6 mm Hg | Standard Deviation 9.86 |
Secondary
Diastolic Blood Pressure at Week 6
Diastolic blood pressure (mm Hg)
Time frame: Week 6
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Diastolic Blood Pressure at Week 6 | 76.6 mm Hg | Standard Deviation 9.86 |
| Nicotine | Diastolic Blood Pressure at Week 6 | 76.5 mm Hg | Standard Deviation 9.49 |
Secondary
Diastolic Blood Pressure at Week 8
Diastolic blood pressure (mm Hg)
Time frame: Week 8
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Diastolic Blood Pressure at Week 8 | 76.5 mm Hg | Standard Deviation 9.82 |
| Nicotine | Diastolic Blood Pressure at Week 8 | 77.3 mm Hg | Standard Deviation 9.35 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 1
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 1
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 1 | 6.0 Number of sprays | Standard Deviation 7.11 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 1 | 4.8 Number of sprays | Standard Deviation 4.93 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 10
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 10
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 10 | 3.2 Number of sprays | Standard Deviation 3.28 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 10 | 2.3 Number of sprays | Standard Deviation 2.19 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 11
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 11
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 11 | 3.0 Number of sprays | Standard Deviation 2.65 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 11 | 2.2 Number of sprays | Standard Deviation 2 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 12
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 12
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 12 | 2.8 Number of sprays | Standard Deviation 2.84 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 12 | 2.0 Number of sprays | Standard Deviation 1.78 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 13
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 13
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 13 | 2.7 Number of sprays | Standard Deviation 2.65 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 13 | 2.2 Number of sprays | Standard Deviation 1.72 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 14
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 14
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 14 | 2.9 Number of sprays | Standard Deviation 2.69 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 14 | 2.2 Number of sprays | Standard Deviation 2.28 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 15
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 15
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 15 | 2.6 Number of sprays | Standard Deviation 2.3 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 15 | 2.4 Number of sprays | Standard Deviation 3.38 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 16
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 16
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 16 | 2.7 Number of sprays | Standard Deviation 3.24 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 16 | 2.1 Number of sprays | Standard Deviation 2.3 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 17
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 17
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 17 | 2.5 Number of sprays | Standard Deviation 2.75 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 17 | 2.1 Number of sprays | Standard Deviation 1.72 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 18
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 18
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 18 | 2.4 Number of sprays | Standard Deviation 2.22 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 18 | 2.3 Number of sprays | Standard Deviation 2.68 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 19
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 19
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 19 | 2.6 Number of sprays | Standard Deviation 3.02 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 19 | 2.3 Number of sprays | Standard Deviation 2.34 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 2
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 2
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 2 | 4.8 Number of sprays | Standard Deviation 6.13 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 2 | 3.4 Number of sprays | Standard Deviation 3.42 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 20
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 20
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 20 | 2.4 Number of sprays | Standard Deviation 2.56 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 20 | 2.0 Number of sprays | Standard Deviation 1.99 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 21
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 21
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 21 | 2.3 Number of sprays | Standard Deviation 2.52 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 21 | 2.1 Number of sprays | Standard Deviation 2.1 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 22
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 22
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 22 | 2.3 Number of sprays | Standard Deviation 2.86 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 22 | 2.0 Number of sprays | Standard Deviation 2.03 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 23
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 23
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 23 | 2.1 Number of sprays | Standard Deviation 1.92 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 23 | 2.0 Number of sprays | Standard Deviation 2.23 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 24
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 24
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 24 | 2.4 Number of sprays | Standard Deviation 4.23 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 24 | 1.9 Number of sprays | Standard Deviation 2.42 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 25
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 25
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 25 | 2.0 Number of sprays | Standard Deviation 2.33 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 25 | 1.8 Number of sprays | Standard Deviation 2.09 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 26
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 26
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 26 | 2.1 Number of sprays | Standard Deviation 2.59 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 26 | 1.8 Number of sprays | Standard Deviation 2.16 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 3
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 3
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 3 | 4.3 Number of sprays | Standard Deviation 4.93 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 3 | 3.1 Number of sprays | Standard Deviation 2.87 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 4
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 4
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 4 | 4.1 Number of sprays | Standard Deviation 4.49 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 4 | 3.0 Number of sprays | Standard Deviation 3.05 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 5
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 5
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 5 | 3.7 Number of sprays | Standard Deviation 3.73 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 5 | 2.8 Number of sprays | Standard Deviation 3.25 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 6
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 6
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 6 | 3.7 Number of sprays | Standard Deviation 4.23 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 6 | 2.7 Number of sprays | Standard Deviation 2.33 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 7
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 7
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 7 | 3.6 Number of sprays | Standard Deviation 4.88 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 7 | 2.9 Number of sprays | Standard Deviation 4.14 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 8
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 8
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 8 | 3.3 Number of sprays | Standard Deviation 3.31 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 8 | 2.6 Number of sprays | Standard Deviation 2.67 |
Secondary
Maximum Hourly Number of Self-Reported Spray Doses at Week 9
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 9
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Hourly Number of Self-Reported Spray Doses at Week 9 | 3.3 Number of sprays | Standard Deviation 3.52 |
| Nicotine | Maximum Hourly Number of Self-Reported Spray Doses at Week 9 | 2.3 Number of sprays | Standard Deviation 2.13 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 1
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 1
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 1 | 22.1 Number of sprays | Standard Deviation 17.66 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 1 | 17.2 Number of sprays | Standard Deviation 11.63 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 10
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 10
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 10 | 14.7 Number of sprays | Standard Deviation 12.47 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 10 | 11.4 Number of sprays | Standard Deviation 10.08 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 11
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 11
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 11 | 15.1 Number of sprays | Standard Deviation 26.23 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 11 | 11.2 Number of sprays | Standard Deviation 11.35 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 12
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 12
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 12 | 12.6 Number of sprays | Standard Deviation 9.7 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 12 | 9.8 Number of sprays | Standard Deviation 8.82 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 13
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 13
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 13 | 12.9 Number of sprays | Standard Deviation 9.78 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 13 | 10.5 Number of sprays | Standard Deviation 9.29 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 14
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 14
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 14 | 13.1 Number of sprays | Standard Deviation 10.95 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 14 | 13.6 Number of sprays | Standard Deviation 40.98 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 15
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 15
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 15 | 15.3 Number of sprays | Standard Deviation 30.31 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 15 | 10.8 Number of sprays | Standard Deviation 12.53 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 16
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 16
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 16 | 12.4 Number of sprays | Standard Deviation 12.8 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 16 | 10.0 Number of sprays | Standard Deviation 9.87 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 17
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 17
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 17 | 11.5 Number of sprays | Standard Deviation 10.19 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 17 | 10.5 Number of sprays | Standard Deviation 9.76 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 18
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 18
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 18 | 12.3 Number of sprays | Standard Deviation 11.94 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 18 | 10.3 Number of sprays | Standard Deviation 10.01 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 19
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 19
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 19 | 11.2 Number of sprays | Standard Deviation 9.85 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 19 | 10.3 Number of sprays | Standard Deviation 10.2 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 2
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 2
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 2 | 21.2 Number of sprays | Standard Deviation 16.83 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 2 | 15.4 Number of sprays | Standard Deviation 10.96 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 20
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 20
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 20 | 10.5 Number of sprays | Standard Deviation 9.38 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 20 | 10.5 Number of sprays | Standard Deviation 11.69 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 21
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 21
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 21 | 10.0 Number of sprays | Standard Deviation 8.82 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 21 | 11.0 Number of sprays | Standard Deviation 13.56 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 22
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 22
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 22 | 9.4 Number of sprays | Standard Deviation 8.89 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 22 | 10.8 Number of sprays | Standard Deviation 16.62 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 23
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 23
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 23 | 10.5 Number of sprays | Standard Deviation 12.79 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 23 | 9.1 Number of sprays | Standard Deviation 9.33 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 24
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 24
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 24 | 9.2 Number of sprays | Standard Deviation 8.5 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 24 | 8.8 Number of sprays | Standard Deviation 9.2 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 25
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 25
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 25 | 8.5 Number of sprays | Standard Deviation 7.24 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 25 | 8.4 Number of sprays | Standard Deviation 9.95 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 26
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 26
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 26 | 8.1 Number of sprays | Standard Deviation 7.3 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 26 | 7.9 Number of sprays | Standard Deviation 7.81 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 3
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 3
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 3 | 19.2 Number of sprays | Standard Deviation 14.78 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 3 | 15.2 Number of sprays | Standard Deviation 13.51 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 4
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 4
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 4 | 17.9 Number of sprays | Standard Deviation 13.58 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 4 | 15.8 Number of sprays | Standard Deviation 23.44 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 5
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 5
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 5 | 19.2 Number of sprays | Standard Deviation 30.71 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 5 | 15.1 Number of sprays | Standard Deviation 27.65 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 6
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 6
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 6 | 17.5 Number of sprays | Standard Deviation 14.59 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 6 | 14.6 Number of sprays | Standard Deviation 24.02 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 7
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 7
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 7 | 16.0 Number of sprays | Standard Deviation 12.39 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 7 | 12.8 Number of sprays | Standard Deviation 11.57 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 8
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 8
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 8 | 16.0 Number of sprays | Standard Deviation 13.05 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 8 | 13.6 Number of sprays | Standard Deviation 14.59 |
Secondary
Maximum Total Daily Number of Self-Reported Spray Doses at Week 9
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 9
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Total Daily Number of Self-Reported Spray Doses at Week 9 | 15.4 Number of sprays | Standard Deviation 13.53 |
| Nicotine | Maximum Total Daily Number of Self-Reported Spray Doses at Week 9 | 12.2 Number of sprays | Standard Deviation 11.01 |
Secondary
Number of Cigarettes Smoked Per Day at Week 12
Number of Cigarettes Smoked Per Day
Time frame: Week 12
Population: Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Cigarettes Smoked Per Day at Week 12 | 7.1 Number of cigarettes | Standard Deviation 5.94 |
| Nicotine | Number of Cigarettes Smoked Per Day at Week 12 | 7.5 Number of cigarettes | Standard Deviation 8.25 |
Secondary
Number of Cigarettes Smoked Per Day at Week 16
Number of Cigarettes Smoked Per Day
Time frame: Week 16
Population: Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Cigarettes Smoked Per Day at Week 16 | 7.7 Number of cigarettes | Standard Deviation 7.71 |
| Nicotine | Number of Cigarettes Smoked Per Day at Week 16 | 7.3 Number of cigarettes | Standard Deviation 6.6 |
Secondary
Number of Cigarettes Smoked Per Day at Week 20
Number of Cigarettes Smoked Per Day
Time frame: Week 20
Population: Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Cigarettes Smoked Per Day at Week 20 | 7.0 Number of cigarettes | Standard Deviation 7.5 |
| Nicotine | Number of Cigarettes Smoked Per Day at Week 20 | 7.2 Number of cigarettes | Standard Deviation 5.9 |
Secondary
Number of Cigarettes Smoked Per Day at Week 26
Number of Cigarettes Smoked Per Day
Time frame: Week 26
Population: Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Cigarettes Smoked Per Day at Week 26 | 7.2 Number of cigarettes | Standard Deviation 6.06 |
| Nicotine | Number of Cigarettes Smoked Per Day at Week 26 | 7.5 Number of cigarettes | Standard Deviation 6.71 |
Secondary
Number of Cigarettes Smoked Per Day at Week 4
Number of Cigarettes Smoked Per Day
Time frame: Week 4
Population: Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Cigarettes Smoked Per Day at Week 4 | 7.3 Number of cigarettes | Standard Deviation 7.77 |
| Nicotine | Number of Cigarettes Smoked Per Day at Week 4 | 6.6 Number of cigarettes | Standard Deviation 8.01 |
Secondary
Number of Cigarettes Smoked Per Day at Week 6
Number of Cigarettes Smoked Per Day
Time frame: Week 6
Population: Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Cigarettes Smoked Per Day at Week 6 | 7.0 Number of cigarettes | Standard Deviation 7.63 |
| Nicotine | Number of Cigarettes Smoked Per Day at Week 6 | 6.6 Number of cigarettes | Standard Deviation 6.25 |
Secondary
Number of Cigarettes Smoked Per Day at Week 8
Number of Cigarettes Smoked Per Day
Time frame: Week 8
Population: Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Cigarettes Smoked Per Day at Week 8 | 6.8 Number of cigarettes | Standard Deviation 5.82 |
| Nicotine | Number of Cigarettes Smoked Per Day at Week 8 | 6.3 Number of cigarettes | Standard Deviation 5.93 |
Secondary
Number of Cigarettes Smoked Since Last Visit at Week 1
Number of Cigarettes Smoked Since Last Visit
Time frame: Week 1
Population: Analysis was based on randomized participants who reported non-abstinence from smoking since last visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Cigarettes Smoked Since Last Visit at Week 1 | 36.2 Number of cigarettes | Standard Deviation 37.89 |
| Nicotine | Number of Cigarettes Smoked Since Last Visit at Week 1 | 34.0 Number of cigarettes | Standard Deviation 40.57 |
Secondary
Number of Cigarettes Smoked Since Last Visit at Week 2
Number of Cigarettes Smoked Since Last Visit
Time frame: Week 2
Population: Analysis was based on randomized participants who reported non-abstinence from smoking since last visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Cigarettes Smoked Since Last Visit at Week 2 | 38.9 Number of cigarettes | Standard Deviation 44.21 |
| Nicotine | Number of Cigarettes Smoked Since Last Visit at Week 2 | 35.8 Number of cigarettes | Standard Deviation 48.2 |
Secondary
Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product
Participants were asked to rate their change of opinion concerning product compared to when first used product on a 5-point scale of 1 - 5 (where 1=I like it much less now and 5=I like it much more now).
Time frame: Week 12
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product | I like it slightly less now (2) | 9.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product | I like it slightly more now (4) | 18.7 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product | I like it about the same (3) | 46.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product | I like it much more now (5) | 17.4 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product | I like it much less now (1) | 9.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product | I like it much more now (5) | 20.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product | I like it much less now (1) | 6.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product | I like it slightly less now (2) | 8.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product | I like it about the same (3) | 44.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product | I like it slightly more now (4) | 20.1 Percentage of Participants |
Secondary
Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product
Participants were asked to rate their change of opinion concerning product compared to when first used product on a 5-point scale of 1 - 5 (where 1=I like it much less now and 5=I like it much more now).
Time frame: Week 1
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product | I like it slightly less now (2) | 4.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product | I like it slightly more now (4) | 26.4 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product | I like it about the same (3) | 50.9 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product | I like it much more now (5) | 15.9 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product | I like it much less now (1) | 2.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product | I like it much more now (5) | 19.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product | I like it much less now (1) | 1.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product | I like it slightly less now (2) | 4.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product | I like it about the same (3) | 44.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product | I like it slightly more now (4) | 28.9 Percentage of Participants |
Secondary
Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product
Participants were asked to rate their change of opinion concerning product compared to when first used product on a 5-point scale of 1 - 5 (where 1=I like it much less now and 5=I like it much more now).
Time frame: Week 6
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product | I like it slightly less now (2) | 11.9 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product | I like it slightly more now (4) | 22.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product | I like it about the same (3) | 47.9 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product | I like it much more now (5) | 13.2 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product | I like it much less now (1) | 4.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product | I like it much more now (5) | 18.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product | I like it much less now (1) | 4.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product | I like it slightly less now (2) | 7.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product | I like it about the same (3) | 46.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product | I like it slightly more now (4) | 22.9 Percentage of Participants |
Secondary
Percentage Distribution of the Participant Score for Overall Product Rating at Week 1
Participants were asked to rate the investigational product on a 10-point scale of 1 - 10 (where 1=very poor and 10=excellent).
Time frame: Week 1
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 1 (Very Poor) | 3.2 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 2 | 3.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 3 | 2.7 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 4 | 6.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 5 | 18.6 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 6 | 9.2 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 7 | 18.6 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 8 | 20.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 9 | 6.7 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 10 (Excellent) | 11.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 8 | 21.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 1 (Very Poor) | 1.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 6 | 8.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 2 | 2.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 10 (Excellent) | 14.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 3 | 3.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 7 | 18.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 4 | 5.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 9 | 7.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | 5 | 16.0 Percentage of Participants |
Secondary
Percentage Distribution of the Participant Score for Overall Product Rating at Week 12
Participants were asked to rate the investigational product on a 10-point scale of 1 - 10 (where 1=very poor and 10=excellent).
Time frame: Week 12
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 1 (Very Poor) | 5.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 2 | 3.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 3 | 3.7 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 4 | 3.7 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 5 | 11.4 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 6 | 10.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 7 | 16.7 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 8 | 20.4 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 9 | 10.9 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 10 (Excellent) | 14.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 8 | 23.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 1 (Very Poor) | 3.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 6 | 6.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 2 | 2.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 10 (Excellent) | 21.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 3 | 3.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 7 | 14.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 4 | 2.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 9 | 11.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | 5 | 12.4 Percentage of Participants |
Secondary
Percentage Distribution of the Participant Score for Overall Product Rating at Week 6
Participants were asked to rate the investigational product on a 10-point scale of 1 - 10 (where 1=very poor and 10=excellent).
Time frame: Week 6
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 1 (Very Poor) | 5.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 2 | 2.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 3 | 4.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 4 | 5.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 5 | 14.9 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 6 | 8.9 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 7 | 18.7 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 8 | 22.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 9 | 8.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 10 (Excellent) | 9.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 8 | 21.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 1 (Very Poor) | 2.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 6 | 10.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 2 | 3.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 10 (Excellent) | 15.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 3 | 3.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 7 | 17.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 4 | 3.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 9 | 10.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | 5 | 12.6 Percentage of Participants |
Secondary
Percentage Distribution of the Participant Score for Product Convenience at Week 1
Participants were asked to rate the product convenience on a 5-point scale of 1 - 5 (where 1=not at all convenient and 5=extremely convenient).
Time frame: Week 1
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Participant Score for Product Convenience at Week 1 | Somewhat convenient (2) | 3.2 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Convenience at Week 1 | Very convenient (4) | 45.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Convenience at Week 1 | Moderately convenient (3) | 10.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Convenience at Week 1 | Extremely convenient (5) | 40.6 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Convenience at Week 1 | Not at all convenient (1) | 0.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Convenience at Week 1 | Extremely convenient (5) | 44.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Convenience at Week 1 | Not at all convenient (1) | 0.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Convenience at Week 1 | Somewhat convenient (2) | 3.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Convenience at Week 1 | Moderately convenient (3) | 10.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Convenience at Week 1 | Very convenient (4) | 41.6 Percentage of Participants |
Secondary
Percentage Distribution of the Participant Score for Product Convenience at Week 12
Participants were asked to rate the product convenience on a 5-point scale of 1 - 5 (where 1=not at all convenient and 5=extremely convenient).
Time frame: Week 12
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Participant Score for Product Convenience at Week 12 | Somewhat convenient (2) | 3.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Convenience at Week 12 | Very convenient (4) | 48.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Convenience at Week 12 | Moderately convenient (3) | 9.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Convenience at Week 12 | Extremely convenient (5) | 38.6 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Convenience at Week 12 | Not at all convenient (1) | 1.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Convenience at Week 12 | Extremely convenient (5) | 42.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Convenience at Week 12 | Not at all convenient (1) | 0.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Convenience at Week 12 | Somewhat convenient (2) | 4.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Convenience at Week 12 | Moderately convenient (3) | 9.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Convenience at Week 12 | Very convenient (4) | 44.2 Percentage of Participants |
Secondary
Percentage Distribution of the Participant Score for Product Convenience at Week 6
Participants were asked to rate the product convenience on a 5-point scale of 1 - 5 (where 1=not at all convenient and 5=extremely convenient).
Time frame: Week 6
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Participant Score for Product Convenience at Week 6 | Somewhat convenient (2) | 4.7 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Convenience at Week 6 | Very convenient (4) | 46.2 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Convenience at Week 6 | Moderately convenient (3) | 8.7 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Convenience at Week 6 | Extremely convenient (5) | 39.6 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Convenience at Week 6 | Not at all convenient (1) | 0.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Convenience at Week 6 | Extremely convenient (5) | 37.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Convenience at Week 6 | Not at all convenient (1) | 0.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Convenience at Week 6 | Somewhat convenient (2) | 3.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Convenience at Week 6 | Moderately convenient (3) | 8.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Convenience at Week 6 | Very convenient (4) | 50.1 Percentage of Participants |
Secondary
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1
Participants were asked to rate the product in its effectiveness for dealing with desire/urge to smoke on a 5-point scale of 1 - 5 (where 1=not all effective and 5=extremely effective).
Time frame: Week 1
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1 | Somewhat effective (2) | 27.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1 | Very effective (4) | 23.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1 | Moderately effective (3) | 34.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1 | Extremely effective (5) | 5.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1 | Not at all effective (1) | 8.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1 | Extremely effective (5) | 12.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1 | Not at all effective (1) | 4.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1 | Somewhat effective (2) | 20.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1 | Moderately effective (3) | 32.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1 | Very effective (4) | 29.8 Percentage of Participants |
Secondary
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12
Participants were asked to rate the product in its effectiveness for dealing with desire/urge to smoke on a 5-point scale of 1 - 5 (where 1=not all effective and 5=extremely effective).
Time frame: Week 12
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12 | Somewhat effective (2) | 20.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12 | Very effective (4) | 25.6 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12 | Moderately effective (3) | 32.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12 | Extremely effective (5) | 9.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12 | Not at all effective (1) | 12.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12 | Extremely effective (5) | 17.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12 | Not at all effective (1) | 6.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12 | Somewhat effective (2) | 17.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12 | Moderately effective (3) | 29.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12 | Very effective (4) | 28.7 Percentage of Participants |
Secondary
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6
Participants were asked to rate the product in its effectiveness for dealing with desire/urge to smoke on a 5-point scale of 1 - 5 (where 1=not all effective and 5=extremely effective).
Time frame: Week 6
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6 | Somewhat effective (2) | 26.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6 | Very effective (4) | 23.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6 | Moderately effective (3) | 31.7 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6 | Extremely effective (5) | 6.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6 | Not at all effective (1) | 11.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6 | Extremely effective (5) | 11.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6 | Not at all effective (1) | 5.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6 | Somewhat effective (2) | 19.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6 | Moderately effective (3) | 32.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6 | Very effective (4) | 31.0 Percentage of Participants |
Secondary
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1
Participants were asked to rate the speed of action of the product on a 9-point scale of 1 - 9 (where 1=extremely slow and 9=extremely fast).
Time frame: Week 1
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Very slow (2) | 2.7 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Sightly fast (6) | 10.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Slightly slow (4) | 6.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Moderately fast (7) | 24.2 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Moderately slow (3) | 4.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Very fast (8) | 17.9 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Neither fast nor slow (5) | 21.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Extremely fast (9) | 8.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Extremely slow (1) | 4.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Extremely fast (9) | 15.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Extremely slow (1) | 1.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Very slow (2) | 1.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Moderately slow (3) | 2.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Slightly slow (4) | 2.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Neither fast nor slow (5) | 14.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Sightly fast (6) | 11.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Moderately fast (7) | 24.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Very fast (8) | 24.9 Percentage of Participants |
Secondary
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12
Participants were asked to rate the speed of action of the product on a 9-point scale of 1 - 9 (where 1=extremely slow and 9=extremely fast).
Time frame: Week 12
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Very slow (2) | 3.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Sightly fast (6) | 8.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Slightly slow (4) | 4.7 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Moderately fast (7) | 28.4 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Moderately slow (3) | 4.2 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Very fast (8) | 17.9 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Neither fast nor slow (5) | 19.4 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Extremely fast (9) | 8.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Extremely slow (1) | 5.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Extremely fast (9) | 15.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Extremely slow (1) | 4.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Very slow (2) | 1.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Moderately slow (3) | 2.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Slightly slow (4) | 3.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Neither fast nor slow (5) | 14.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Sightly fast (6) | 8.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Moderately fast (7) | 21.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Very fast (8) | 28.3 Percentage of Participants |
Secondary
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6
Participants were asked to rate the speed of action of the product on a 9-point scale of 1 - 9 (where 1=extremely slow and 9=extremely fast).
Time frame: Week 6
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Neither fast nor slow (5) | 20.2 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Moderately slow (3) | 4.7 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Sightly fast (6) | 11.9 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Very slow (2) | 4.9 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Moderately fast (7) | 24.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Slightly slow (4) | 4.7 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Very fast (8) | 18.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Extremely fast (9) | 5.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Extremely slow (1) | 5.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Extremely fast (9) | 14.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Extremely slow (1) | 2.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Very slow (2) | 2.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Moderately slow (3) | 3.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Slightly slow (4) | 3.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Neither fast nor slow (5) | 13.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Sightly fast (6) | 9.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Moderately fast (7) | 25.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Very fast (8) | 25.1 Percentage of Participants |
Secondary
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1
Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 1
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1 | Somewhat (1) | 28.6 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1 | Very much so (3) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1 | Moderately so (2) | 19.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1 | Not at all (0) | 52.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1 | Extremely so (4) | 5.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1 | Not at all (0) | 59.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1 | Somewhat (1) | 28.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1 | Moderately so (2) | 7.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1 | Very much so (3) | 0.0 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.p-value: 0.60895% CI: [-0.54, 0.49]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2
Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 2
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2 | Somewhat (1) | 24.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2 | Very much so (3) | 12.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2 | Moderately so (2) | 12.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2 | Extremely so (4) | 8.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2 | Not at all (0) | 44.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2 | Extremely so (4) | 3.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2 | Not at all (0) | 72.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2 | Somewhat (1) | 12.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2 | Moderately so (2) | 8.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2 | Very much so (3) | 3.4 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.p-value: 0.01495% CI: [-1.16, -0.09]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4
Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 4
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4 | Somewhat (1) | 26.9 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4 | Very much so (3) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4 | Moderately so (2) | 7.7 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4 | Not at all (0) | 65.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4 | Extremely so (4) | 0.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4 | Not at all (0) | 65.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4 | Somewhat (1) | 23.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4 | Moderately so (2) | 11.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4 | Very much so (3) | 0.0 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.p-value: 0.995% CI: [-0.3, 0.38]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6
Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 6
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6 | Somewhat (1) | 25.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6 | Very much so (3) | 6.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6 | Moderately so (2) | 6.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6 | Not at all (0) | 62.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6 | Extremely so (4) | 0.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6 | Not at all (0) | 66.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6 | Somewhat (1) | 20.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6 | Moderately so (2) | 9.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6 | Very much so (3) | 3.7 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.p-value: 0.73195% CI: [-0.44, 0.31]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1
Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 1
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 | Somewhat (1) | 33.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 | Very much so (3) | 19.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 | Moderately so (2) | 33.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 | Extremely so (4) | 4.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 | Not at all (0) | 9.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 | Extremely so (4) | 10.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 | Not at all (0) | 12.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 | Somewhat (1) | 35.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 | Moderately so (2) | 25.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 | Very much so (3) | 15.4 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.p-value: 0.84795% CI: [-0.64, 0.6]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2
Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 2
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2 | Somewhat (1) | 28.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2 | Very much so (3) | 20.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2 | Moderately so (2) | 20.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2 | Extremely so (4) | 8.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2 | Not at all (0) | 24.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2 | Extremely so (4) | 3.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2 | Not at all (0) | 15.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2 | Somewhat (1) | 36.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2 | Moderately so (2) | 34.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2 | Very much so (3) | 10.3 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.p-value: 0.86195% CI: [-0.62, 0.42]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4
Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 4
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4 | Somewhat (1) | 53.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4 | Very much so (3) | 3.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4 | Moderately so (2) | 23.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4 | Not at all (0) | 19.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4 | Extremely so (4) | 0.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4 | Not at all (0) | 37.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4 | Somewhat (1) | 39.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4 | Moderately so (2) | 16.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4 | Very much so (3) | 7.0 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.p-value: 0.26695% CI: [-0.61, 0.24]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6
Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 6
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6 | Somewhat (1) | 31.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6 | Very much so (3) | 9.4 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6 | Moderately so (2) | 12.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6 | Extremely so (4) | 3.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6 | Not at all (0) | 43.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6 | Extremely so (4) | 3.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6 | Not at all (0) | 31.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6 | Somewhat (1) | 42.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6 | Moderately so (2) | 18.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6 | Very much so (3) | 3.7 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.p-value: 0.48795% CI: [-0.38, 0.55]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1
Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 1
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1 | Somewhat (1) | 23.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1 | Very much so (3) | 4.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1 | Moderately so (2) | 4.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1 | Not at all (0) | 66.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1 | Extremely so (4) | 0.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1 | Not at all (0) | 69.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1 | Somewhat (1) | 17.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1 | Moderately so (2) | 7.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1 | Very much so (3) | 5.1 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.p-value: 0.92595% CI: [-0.44, 0.47]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2
Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 2
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2 | Somewhat (1) | 32.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2 | Very much so (3) | 4.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2 | Moderately so (2) | 8.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2 | Extremely so (4) | 4.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2 | Not at all (0) | 52.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2 | Extremely so (4) | 1.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2 | Not at all (0) | 63.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2 | Somewhat (1) | 24.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2 | Moderately so (2) | 6.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2 | Very much so (3) | 3.4 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.p-value: 0.32595% CI: [-0.66, 0.24]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4
Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 4
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4 | Somewhat (1) | 23.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4 | Very much so (3) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4 | Moderately so (2) | 3.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4 | Not at all (0) | 73.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4 | Extremely so (4) | 0.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4 | Not at all (0) | 74.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4 | Somewhat (1) | 11.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4 | Moderately so (2) | 9.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4 | Very much so (3) | 4.7 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.p-value: 0.89195% CI: [-0.24, 0.51]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6
Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 6
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6 | Somewhat (1) | 12.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6 | Very much so (3) | 6.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6 | Moderately so (2) | 9.4 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6 | Not at all (0) | 71.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6 | Extremely so (4) | 0.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6 | Not at all (0) | 74.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6 | Somewhat (1) | 16.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6 | Moderately so (2) | 5.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6 | Very much so (3) | 3.7 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.p-value: 0.72195% CI: [-0.48, 0.25]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1
Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 1
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1 | Somewhat (1) | 19.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1 | Very much so (3) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1 | Moderately so (2) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1 | Not at all (0) | 81.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1 | Extremely so (4) | 0.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1 | Not at all (0) | 87.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1 | Somewhat (1) | 5.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1 | Moderately so (2) | 5.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1 | Very much so (3) | 2.6 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.p-value: 0.63595% CI: [-0.28, 0.36]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2
Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 2
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2 | Somewhat (1) | 20.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2 | Very much so (3) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2 | Moderately so (2) | 8.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2 | Not at all (0) | 72.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2 | Extremely so (4) | 1.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2 | Not at all (0) | 84.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2 | Somewhat (1) | 5.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2 | Moderately so (2) | 6.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2 | Very much so (3) | 1.7 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.p-value: 0.27395% CI: [-0.42, 0.32]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4
Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 4
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4 | Somewhat (1) | 11.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4 | Very much so (3) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4 | Moderately so (2) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4 | Extremely so (4) | 3.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4 | Not at all (0) | 84.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4 | Extremely so (4) | 0.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4 | Not at all (0) | 86.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4 | Somewhat (1) | 9.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4 | Moderately so (2) | 2.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4 | Very much so (3) | 2.3 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.p-value: 0.87995% CI: [-0.4, 0.28]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6
Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 6
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6 | Somewhat (1) | 15.6 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6 | Very much so (3) | 3.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6 | Moderately so (2) | 3.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6 | Not at all (0) | 78.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6 | Extremely so (4) | 0.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6 | Not at all (0) | 75.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6 | Somewhat (1) | 16.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6 | Moderately so (2) | 5.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6 | Very much so (3) | 1.9 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.p-value: 0.82395% CI: [-0.28, 0.32]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1
Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 1
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1 | Somewhat (1) | 52.4 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1 | Very much so (3) | 14.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1 | Moderately so (2) | 23.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1 | Not at all (0) | 9.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1 | Extremely so (4) | 5.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1 | Not at all (0) | 43.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1 | Somewhat (1) | 28.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1 | Moderately so (2) | 5.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1 | Very much so (3) | 17.9 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.p-value: 0.10595% CI: [-0.93, 0.33]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2
Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 2
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2 | Somewhat (1) | 36.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2 | Very much so (3) | 12.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2 | Moderately so (2) | 24.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2 | Not at all (0) | 28.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2 | Extremely so (4) | 3.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2 | Not at all (0) | 41.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2 | Somewhat (1) | 25.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2 | Moderately so (2) | 12.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2 | Very much so (3) | 17.2 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.p-value: 0.60495% CI: [-0.6, 0.51]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4
Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 4
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4 | Very much so (3) | 15.4 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4 | Not at all (0) | 30.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4 | Somewhat (1) | 26.9 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4 | Moderately so (2) | 23.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4 | Extremely so (4) | 3.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4 | Extremely so (4) | 4.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4 | Moderately so (2) | 11.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4 | Not at all (0) | 44.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4 | Very much so (3) | 9.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4 | Somewhat (1) | 30.2 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.p-value: 0.19495% CI: [-0.93, 0.24]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6
Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 6
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6 | Somewhat (1) | 43.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6 | Very much so (3) | 12.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6 | Moderately so (2) | 18.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6 | Extremely so (4) | 3.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6 | Not at all (0) | 21.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6 | Extremely so (4) | 3.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6 | Not at all (0) | 35.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6 | Somewhat (1) | 31.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6 | Moderately so (2) | 14.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6 | Very much so (3) | 14.8 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.p-value: 0.50295% CI: [-0.62, 0.4]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1
Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 1
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1 | Somewhat (1) | 14.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1 | Very much so (3) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1 | Moderately so (2) | 9.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1 | Not at all (0) | 76.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1 | Extremely so (4) | 0.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1 | Not at all (0) | 79.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1 | Somewhat (1) | 12.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1 | Moderately so (2) | 2.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1 | Very much so (3) | 5.1 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.p-value: 0.80495% CI: [-0.4, 0.4]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2
Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 2
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2 | Somewhat (1) | 16.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2 | Very much so (3) | 8.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2 | Moderately so (2) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2 | Not at all (0) | 76.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2 | Extremely so (4) | 1.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2 | Not at all (0) | 67.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2 | Somewhat (1) | 20.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2 | Moderately so (2) | 5.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2 | Very much so (3) | 5.2 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.p-value: 0.43895% CI: [-0.3, 0.57]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4
Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 4
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4 | Somewhat (1) | 26.9 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4 | Very much so (3) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4 | Moderately so (2) | 11.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4 | Not at all (0) | 61.5 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4 | Extremely so (4) | 0.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4 | Not at all (0) | 69.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4 | Somewhat (1) | 20.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4 | Moderately so (2) | 7.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4 | Very much so (3) | 2.3 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.p-value: 0.51795% CI: [-0.44, 0.28]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6
Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 6
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6 | Somewhat (1) | 21.9 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6 | Very much so (3) | 6.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6 | Not at all (0) | 62.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6 | Extremely so (4) | 3.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6 | Moderately so (2) | 6.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6 | Extremely so (4) | 0.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6 | Somewhat (1) | 11.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6 | Moderately so (2) | 3.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6 | Very much so (3) | 1.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6 | Not at all (0) | 83.3 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.p-value: 0.02795% CI: [-0.77, -0.06]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1
Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 1
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1 | Somewhat (1) | 38.1 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1 | Very much so (3) | 4.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1 | Moderately so (2) | 19.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1 | Not at all (0) | 38.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1 | Extremely so (4) | 5.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1 | Not at all (0) | 51.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1 | Somewhat (1) | 28.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1 | Moderately so (2) | 15.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1 | Very much so (3) | 0.0 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.p-value: 0.43395% CI: [-0.65, 0.43]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2
Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 2
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2 | Somewhat (1) | 40.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2 | Very much so (3) | 8.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2 | Moderately so (2) | 12.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2 | Extremely so (4) | 12.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2 | Not at all (0) | 28.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2 | Extremely so (4) | 5.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2 | Not at all (0) | 56.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2 | Somewhat (1) | 24.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2 | Moderately so (2) | 8.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2 | Very much so (3) | 5.2 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.p-value: 0.02295% CI: [-1.15, -0.01]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4
Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 4
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4 | Somewhat (1) | 34.6 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4 | Very much so (3) | 3.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4 | Moderately so (2) | 15.4 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4 | Not at all (0) | 46.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4 | Extremely so (4) | 2.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4 | Not at all (0) | 55.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4 | Somewhat (1) | 23.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4 | Moderately so (2) | 11.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4 | Very much so (3) | 7.0 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.p-value: 0.66595% CI: [-0.5, 0.49]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6
Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 6
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6 | Somewhat (1) | 43.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6 | Very much so (3) | 6.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6 | Moderately so (2) | 6.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6 | Not at all (0) | 43.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6 | Extremely so (4) | 1.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6 | Not at all (0) | 61.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6 | Somewhat (1) | 20.4 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6 | Moderately so (2) | 13.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6 | Very much so (3) | 3.7 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.p-value: 0.395% CI: [-0.51, 0.31]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1
Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 1
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1 | Somewhat (1) | 14.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1 | Very much so (3) | 9.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1 | Moderately so (2) | 23.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1 | Extremely so (4) | 4.8 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1 | Not at all (0) | 47.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1 | Extremely so (4) | 2.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1 | Not at all (0) | 43.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1 | Somewhat (1) | 30.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1 | Moderately so (2) | 17.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1 | Very much so (3) | 5.1 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.p-value: 0.75495% CI: [-0.78, 0.43]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2
Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 2
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2 | Somewhat (1) | 32.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2 | Very much so (3) | 12.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2 | Moderately so (2) | 12.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2 | Extremely so (4) | 4.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2 | Not at all (0) | 40.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2 | Extremely so (4) | 1.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2 | Not at all (0) | 58.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2 | Somewhat (1) | 20.7 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2 | Moderately so (2) | 17.2 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2 | Very much so (3) | 1.7 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.p-value: 0.11695% CI: [-0.89, 0.08]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4
Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 4
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4 | Somewhat (1) | 34.6 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4 | Very much so (3) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4 | Moderately so (2) | 11.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4 | Not at all (0) | 53.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4 | Extremely so (4) | 0.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4 | Not at all (0) | 62.8 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4 | Somewhat (1) | 32.6 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4 | Moderately so (2) | 2.3 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4 | Very much so (3) | 2.3 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.p-value: 0.39295% CI: [-0.47, 0.2]Wilcoxon (Mann-Whitney)
Secondary
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6
Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Time frame: Week 6
Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6 | Somewhat (1) | 37.5 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6 | Very much so (3) | 6.3 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6 | Moderately so (2) | 9.4 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6 | Extremely so (4) | 0.0 Percentage of Participants |
| Placebo | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6 | Not at all (0) | 46.9 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6 | Extremely so (4) | 0.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6 | Not at all (0) | 63.0 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6 | Somewhat (1) | 24.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6 | Moderately so (2) | 11.1 Percentage of Participants |
| Nicotine | Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6 | Very much so (3) | 1.9 Percentage of Participants |
Comparison: The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.p-value: 0.17995% CI: [-0.59, 0.13]Wilcoxon (Mann-Whitney)
Secondary
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Time frame: Week 2 to Week 12
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12 | 1.3 Percentage of Participants |
| Nicotine | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12 | 4.0 Percentage of Participants |
Comparison: The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.p-value: 0.00495% CI: [1.39, 6.68]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Time frame: Week 2 to Week 16
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16 | 1.3 Percentage of Participants |
| Nicotine | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16 | 3.9 Percentage of Participants |
Comparison: The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.p-value: 0.00695% CI: [1.32, 6.42]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Time frame: Week 2 to Week 20
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20 | 1.3 Percentage of Participants |
| Nicotine | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20 | 3.5 Percentage of Participants |
Comparison: The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.p-value: 0.01395% CI: [1.2, 5.92]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Time frame: Week 2 to Week 26
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26 | 1.2 Percentage of Participants |
| Nicotine | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26 | 3.4 Percentage of Participants |
Comparison: The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.p-value: 0.01195% CI: [1.23, 6.71]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Time frame: Week 2 to Week 4
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4 | 4.0 Percentage of Participants |
| Nicotine | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4 | 6.7 Percentage of Participants |
Comparison: The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.p-value: 0.0495% CI: [1.02, 2.71]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Time frame: Week 2 to Week 8
Population: Analysis was based on the Full Analysis Set which included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8 | 2.2 Percentage of Participants |
| Nicotine | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8 | 4.5 Percentage of Participants |
Comparison: The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.p-value: 0.02395% CI: [1.09, 3.98]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With New or Worsened Conditions in Buccal Mucosa at Week 6 or When Withdrawn From Study
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Time frame: Week 6 or when withdrawn from study
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With New or Worsened Conditions in Buccal Mucosa at Week 6 or When Withdrawn From Study | 1.2 Percentage of Participants |
| Nicotine | Percentage of Participants With New or Worsened Conditions in Buccal Mucosa at Week 6 or When Withdrawn From Study | 1.6 Percentage of Participants |
Secondary
Percentage of Participants With New or Worsened Conditions in Gingiva at Week 6 or When Withdrawn From Study
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Time frame: Week 6 or when withdrawn from study
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With New or Worsened Conditions in Gingiva at Week 6 or When Withdrawn From Study | 0.2 Percentage of Participants |
| Nicotine | Percentage of Participants With New or Worsened Conditions in Gingiva at Week 6 or When Withdrawn From Study | 1.0 Percentage of Participants |
Secondary
Percentage of Participants With New or Worsened Conditions in Hard/Soft Palate at Week 6 or When Withdrawn From Study
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Time frame: Week 6 or when withdrawn from study
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With New or Worsened Conditions in Hard/Soft Palate at Week 6 or When Withdrawn From Study | 0.4 Percentage of Participants |
| Nicotine | Percentage of Participants With New or Worsened Conditions in Hard/Soft Palate at Week 6 or When Withdrawn From Study | 1.0 Percentage of Participants |
Secondary
Percentage of Participants With New or Worsened Conditions in Lips/Labial Mucosa at Week 6 or When Withdrawn From Study
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Time frame: Week 6 or when withdrawn from study
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With New or Worsened Conditions in Lips/Labial Mucosa at Week 6 or When Withdrawn From Study | 0.4 Percentage of Participants |
| Nicotine | Percentage of Participants With New or Worsened Conditions in Lips/Labial Mucosa at Week 6 or When Withdrawn From Study | 1.0 Percentage of Participants |
Secondary
Percentage of Participants With New or Worsened Conditions in Mucobuccal Fold at Week 6 or When Withdrawn From Study
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Time frame: Week 6 or when withdrawn from study
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With New or Worsened Conditions in Mucobuccal Fold at Week 6 or When Withdrawn From Study | 0.2 Percentage of Participants |
| Nicotine | Percentage of Participants With New or Worsened Conditions in Mucobuccal Fold at Week 6 or When Withdrawn From Study | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With New or Worsened Conditions in Sublingual Mucosa at Week 6 or When Withdrawn From Study
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Time frame: Week 6 or when withdrawn from study
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With New or Worsened Conditions in Sublingual Mucosa at Week 6 or When Withdrawn From Study | 0.0 Percentage of Participants |
| Nicotine | Percentage of Participants With New or Worsened Conditions in Sublingual Mucosa at Week 6 or When Withdrawn From Study | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With New or Worsened Conditions in Tongue at Week 6 or When Withdrawn From Study
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Time frame: Week 6 or when withdrawn from study
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With New or Worsened Conditions in Tongue at Week 6 or When Withdrawn From Study | 0.8 Percentage of Participants |
| Nicotine | Percentage of Participants With New or Worsened Conditions in Tongue at Week 6 or When Withdrawn From Study | 0.8 Percentage of Participants |
Secondary
Percentage of Participants With New or Worsened Conditions in Uvula/Oropharynx at Week 6 or When Withdrawn From Study
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Time frame: Week 6 or when withdrawn from study
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With New or Worsened Conditions in Uvula/Oropharynx at Week 6 or When Withdrawn From Study | 0.4 Percentage of Participants |
| Nicotine | Percentage of Participants With New or Worsened Conditions in Uvula/Oropharynx at Week 6 or When Withdrawn From Study | 0.2 Percentage of Participants |
Secondary
Percentage of Participants With New or Worsened Conditions in Visual Mouth Inspection Overall at Week 6 or When Withdrawn From Study
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Time frame: Week 6 or when withdrawn from study
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With New or Worsened Conditions in Visual Mouth Inspection Overall at Week 6 or When Withdrawn From Study | 1.8 Percentage of Participants |
| Nicotine | Percentage of Participants With New or Worsened Conditions in Visual Mouth Inspection Overall at Week 6 or When Withdrawn From Study | 3.6 Percentage of Participants |
Secondary
Pulse at Week 1
Pulse (beats per minute)
Time frame: Week 1
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pulse at Week 1 | 76.1 beats per minute | Standard Deviation 11.92 |
| Nicotine | Pulse at Week 1 | 76.8 beats per minute | Standard Deviation 11.45 |
Secondary
Pulse at Week 12
Pulse (beats per minute)
Time frame: Week 12
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pulse at Week 12 | 75.1 beats per minute | Standard Deviation 11.46 |
| Nicotine | Pulse at Week 12 | 76.1 beats per minute | Standard Deviation 11.02 |
Secondary
Pulse at Week 16
Pulse (beats per minute)
Time frame: Week 16
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pulse at Week 16 | 76.9 beats per minute | Standard Deviation 11.94 |
| Nicotine | Pulse at Week 16 | 76.2 beats per minute | Standard Deviation 11.46 |
Secondary
Pulse at Week 2
Pulse (beats per minute)
Time frame: Week 2
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pulse at Week 2 | 75.9 beats per minute | Standard Deviation 11.82 |
| Nicotine | Pulse at Week 2 | 76.5 beats per minute | Standard Deviation 11.64 |
Secondary
Pulse at Week 20
Pulse (beats per minute)
Time frame: Week 20
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pulse at Week 20 | 76.4 beats per minute | Standard Deviation 11.7 |
| Nicotine | Pulse at Week 20 | 76.2 beats per minute | Standard Deviation 11.58 |
Secondary
Pulse at Week 26
Pulse (beats per minute)
Time frame: Week 26
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pulse at Week 26 | 76.9 beats per minute | Standard Deviation 11.98 |
| Nicotine | Pulse at Week 26 | 76.0 beats per minute | Standard Deviation 10.85 |
Secondary
Pulse at Week 4
Pulse (beats per minute)
Time frame: Week 4
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pulse at Week 4 | 75.6 beats per minute | Standard Deviation 11.77 |
| Nicotine | Pulse at Week 4 | 77.0 beats per minute | Standard Deviation 11.72 |
Secondary
Pulse at Week 6
Pulse (beats per minute)
Time frame: Week 6
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pulse at Week 6 | 75.3 beats per minute | Standard Deviation 11.41 |
| Nicotine | Pulse at Week 6 | 75.2 beats per minute | Standard Deviation 11.37 |
Secondary
Pulse at Week 8
Pulse (beats per minute)
Time frame: Week 8
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pulse at Week 8 | 75.4 beats per minute | Standard Deviation 11.69 |
| Nicotine | Pulse at Week 8 | 77.3 beats per minute | Standard Deviation 11.27 |
Secondary
Systolic Blood Pressure at Week 1
Systolic blood pressure (mm Hg)
Time frame: Week 1
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Systolic Blood Pressure at Week 1 | 123.7 mm Hg | Standard Deviation 15.54 |
| Nicotine | Systolic Blood Pressure at Week 1 | 124.7 mm Hg | Standard Deviation 15.84 |
Secondary
Systolic Blood Pressure at Week 12
Systolic blood pressure (mm Hg)
Time frame: Week 12
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Systolic Blood Pressure at Week 12 | 121.8 mm Hg | Standard Deviation 15.02 |
| Nicotine | Systolic Blood Pressure at Week 12 | 122.7 mm Hg | Standard Deviation 15.81 |
Secondary
Systolic Blood Pressure at Week 16
Systolic blood pressure (mm Hg)
Time frame: Week 16
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Systolic Blood Pressure at Week 16 | 122.3 mm Hg | Standard Deviation 14.94 |
| Nicotine | Systolic Blood Pressure at Week 16 | 122.8 mm Hg | Standard Deviation 15.25 |
Secondary
Systolic Blood Pressure at Week 2
Systolic blood pressure (mm Hg)
Time frame: Week 2
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Systolic Blood Pressure at Week 2 | 123.3 mm Hg | Standard Deviation 15.42 |
| Nicotine | Systolic Blood Pressure at Week 2 | 123.7 mm Hg | Standard Deviation 15.5 |
Secondary
Systolic Blood Pressure at Week 20
Systolic blood pressure (mm Hg)
Time frame: Week 20
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Systolic Blood Pressure at Week 20 | 122.4 mm Hg | Standard Deviation 15.4 |
| Nicotine | Systolic Blood Pressure at Week 20 | 123.2 mm Hg | Standard Deviation 15.41 |
Secondary
Systolic Blood Pressure at Week 26
Systolic blood pressure (mm Hg)
Time frame: Week 26
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Systolic Blood Pressure at Week 26 | 123.2 mm Hg | Standard Deviation 14.44 |
| Nicotine | Systolic Blood Pressure at Week 26 | 124.8 mm Hg | Standard Deviation 15.07 |
Secondary
Systolic Blood Pressure at Week 4
Systolic blood pressure (mm Hg)
Time frame: Week 4
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Systolic Blood Pressure at Week 4 | 122.5 mm Hg | Standard Deviation 15.29 |
| Nicotine | Systolic Blood Pressure at Week 4 | 122.9 mm Hg | Standard Deviation 15.55 |
Secondary
Systolic Blood Pressure at Week 6
Systolic blood pressure (mm Hg)
Time frame: Week 6
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Systolic Blood Pressure at Week 6 | 122.3 mm Hg | Standard Deviation 14.05 |
| Nicotine | Systolic Blood Pressure at Week 6 | 122.4 mm Hg | Standard Deviation 15.04 |
Secondary
Systolic Blood Pressure at Week 8
Systolic blood pressure (mm Hg)
Time frame: Week 8
Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Systolic Blood Pressure at Week 8 | 122.0 mm Hg | Standard Deviation 14.52 |
| Nicotine | Systolic Blood Pressure at Week 8 | 122.7 mm Hg | Standard Deviation 14.86 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 1
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 1
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 1 | 15.6 Number of sprays | Standard Deviation 10.77 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 1 | 12.3 Number of sprays | Standard Deviation 8.78 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 10
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 10
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 10 | 11.6 Number of sprays | Standard Deviation 9.86 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 10 | 9.3 Number of sprays | Standard Deviation 8.66 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 11
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 11
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 11 | 11.3 Number of sprays | Standard Deviation 9.8 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 11 | 8.8 Number of sprays | Standard Deviation 8.55 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 12
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 12
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 12 | 9.7 Number of sprays | Standard Deviation 7.69 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 12 | 7.9 Number of sprays | Standard Deviation 7.9 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 13
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 13
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 13 | 10.2 Number of sprays | Standard Deviation 8.28 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 13 | 8.4 Number of sprays | Standard Deviation 8.36 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 14
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 14
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 14 | 10.3 Number of sprays | Standard Deviation 9.2 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 14 | 9.2 Number of sprays | Standard Deviation 12.88 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 15
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 15
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 15 | 10.5 Number of sprays | Standard Deviation 9.66 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 15 | 8.2 Number of sprays | Standard Deviation 8.47 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 16
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 16
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 16 | 9.2 Number of sprays | Standard Deviation 8.7 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 16 | 8.0 Number of sprays | Standard Deviation 8.47 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 17
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 17
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 17 | 9.2 Number of sprays | Standard Deviation 8.58 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 17 | 8.0 Number of sprays | Standard Deviation 7.56 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 18
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 18
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 18 | 9.4 Number of sprays | Standard Deviation 8.84 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 18 | 8.2 Number of sprays | Standard Deviation 8.8 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 19
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 19
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 19 | 9.1 Number of sprays | Standard Deviation 8.49 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 19 | 8.3 Number of sprays | Standard Deviation 8.59 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 2
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 2
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 2 | 15.7 Number of sprays | Standard Deviation 12.08 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 2 | 11.8 Number of sprays | Standard Deviation 9.19 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 20
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 20
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 20 | 7.8 Number of sprays | Standard Deviation 6.94 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 20 | 8.2 Number of sprays | Standard Deviation 8.5 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 21
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 21
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 21 | 7.8 Number of sprays | Standard Deviation 7.32 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 21 | 8.2 Number of sprays | Standard Deviation 8.84 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 22
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 22
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 22 | 7.5 Number of sprays | Standard Deviation 7.27 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 22 | 7.8 Number of sprays | Standard Deviation 8.32 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 23
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 23
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 23 | 7.7 Number of sprays | Standard Deviation 6.97 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 23 | 7.4 Number of sprays | Standard Deviation 8.04 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 24
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 24
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 24 | 7.2 Number of sprays | Standard Deviation 6.5 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 24 | 7.2 Number of sprays | Standard Deviation 8.09 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 25
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 25
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 25 | 6.6 Number of sprays | Standard Deviation 6.08 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 25 | 6.7 Number of sprays | Standard Deviation 7.95 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 26
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 26
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 26 | 6.3 Number of sprays | Standard Deviation 5.91 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 26 | 6.3 Number of sprays | Standard Deviation 6.81 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 3
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 3
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 3 | 14.6 Number of sprays | Standard Deviation 11.15 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 3 | 11.6 Number of sprays | Standard Deviation 9.31 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 4
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 4
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 4 | 13.8 Number of sprays | Standard Deviation 11.05 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 4 | 11.3 Number of sprays | Standard Deviation 10.66 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 5
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 5
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 5 | 14.2 Number of sprays | Standard Deviation 12.17 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 5 | 10.9 Number of sprays | Standard Deviation 9.91 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 6
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 6
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 6 | 13.1 Number of sprays | Standard Deviation 10.49 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 6 | 10.5 Number of sprays | Standard Deviation 9.71 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 7
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 7
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 7 | 12.3 Number of sprays | Standard Deviation 9.63 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 7 | 9.9 Number of sprays | Standard Deviation 8.8 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 8
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 8
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 8 | 12.1 Number of sprays | Standard Deviation 10.15 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 8 | 10.1 Number of sprays | Standard Deviation 8.9 |
Secondary
Total Daily Number of Self-Reported Spray Doses at Week 9
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 9
Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Number of Self-Reported Spray Doses at Week 9 | 11.8 Number of sprays | Standard Deviation 9.98 |
| Nicotine | Total Daily Number of Self-Reported Spray Doses at Week 9 | 9.7 Number of sprays | Standard Deviation 8.92 |