| 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 | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 2 to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| | | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| 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. | Cochran-Mantel-Haenszel | Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (<20 per day vs ≥20 per day). | 0.021 | The significance threshold level was 0.05 (two-sided). | Estimated Success Rate Ratio | 2.00 | | | 2-Sided | 95 | 1.10 | 3.66 | | | Estimated Success Rate Ratio = Nicotine/Placebo | | |
|
| 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 | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 2 to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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 | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 2 to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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 | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 2 to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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 | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 2 to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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 | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 2 to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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 | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 2 to Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Number | | Percentage of Participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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. | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Mean | Standard Deviation | units on a scale | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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. | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Mean | Standard Deviation | units on a scale | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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. | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Mean | Standard Deviation | units on a scale | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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. | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Posted | | Mean | Standard Deviation | units on a scale | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 1 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 2 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 3 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 3 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 4 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 5 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 5 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 6 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 7 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 7 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 8 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 9 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 9 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 10 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 11 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 12 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 13 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 14 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 15 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 15 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 16 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 17 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 17 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 18 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 19 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 19 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 20 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 21 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 21 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 22 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 23 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 23 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 24 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 25 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Total Daily Number of Self-Reported Spray Doses at Week 26 | Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 1 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 2 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 3 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 3 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 4 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 5 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 5 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 6 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 7 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 7 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 8 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 9 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 9 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 10 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 11 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 12 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 13 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 14 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 15 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 15 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 16 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 17 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 17 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 18 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 19 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 19 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 20 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 21 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 21 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 22 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 23 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 23 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 24 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 25 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Total Daily Number of Self-Reported Spray Doses at Week 26 | Maximum Total Daily Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 1 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 2 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 3 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 3 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 4 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 5 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 5 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 6 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 7 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 7 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 8 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 9 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 9 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 10 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 11 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 12 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 13 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 14 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 15 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 15 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 16 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 17 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 17 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 18 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 19 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 19 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 20 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 21 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 21 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 22 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 23 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 23 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 24 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 25 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Maximum Hourly Number of Self-Reported Spray Doses at Week 26 | Maximum Hourly Number of Self-Reported Spray Doses | Analysis was based on randomized participants who reported use data for at least 4 of the days in that week. | Posted | | Mean | Standard Deviation | Number of sprays | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Number of Cigarettes Smoked Since Last Visit at Week 1 | Number of Cigarettes Smoked Since Last Visit | Analysis was based on randomized participants who reported non-abstinence from smoking since last visit. | Posted | | Mean | Standard Deviation | Number of cigarettes | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Number of Cigarettes Smoked Since Last Visit at Week 2 | Number of Cigarettes Smoked Since Last Visit | Analysis was based on randomized participants who reported non-abstinence from smoking since last visit. | Posted | | Mean | Standard Deviation | Number of cigarettes | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Number of Cigarettes Smoked Per Day at Week 4 | Number of Cigarettes Smoked Per Day | Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week. | Posted | | Mean | Standard Deviation | Number of cigarettes | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Number of Cigarettes Smoked Per Day at Week 6 | Number of Cigarettes Smoked Per Day | Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week. | Posted | | Mean | Standard Deviation | Number of cigarettes | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Number of Cigarettes Smoked Per Day at Week 8 | Number of Cigarettes Smoked Per Day | Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week. | Posted | | Mean | Standard Deviation | Number of cigarettes | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Number of Cigarettes Smoked Per Day at Week 12 | Number of Cigarettes Smoked Per Day | Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week. | Posted | | Mean | Standard Deviation | Number of cigarettes | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Number of Cigarettes Smoked Per Day at Week 16 | Number of Cigarettes Smoked Per Day | Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week. | Posted | | Mean | Standard Deviation | Number of cigarettes | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Number of Cigarettes Smoked Per Day at Week 20 | Number of Cigarettes Smoked Per Day | Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week. | Posted | | Mean | Standard Deviation | Number of cigarettes | | Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Number of Cigarettes Smoked Per Day at Week 26 | Number of Cigarettes Smoked Per Day | Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week. | Posted | | Mean | Standard Deviation | Number of cigarettes | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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). | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Number | | Percentage of Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Systolic Blood Pressure at Week 1 | Systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Systolic Blood Pressure at Week 2 | Systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Systolic Blood Pressure at Week 4 | Systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Systolic Blood Pressure at Week 6 | Systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Systolic Blood Pressure at Week 8 | Systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Systolic Blood Pressure at Week 12 | Systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Systolic Blood Pressure at Week 16 | Systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Systolic Blood Pressure at Week 20 | Systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Systolic Blood Pressure at Week 26 | Systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Systolic Blood Pressure at Week 1 | Change from baseline in systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Systolic Blood Pressure at Week 2 | Change from baseline in systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Systolic Blood Pressure at Week 4 | Change from baseline in systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Systolic Blood Pressure at Week 6 | Change from baseline in systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Systolic Blood Pressure at Week 8 | Change from baseline in systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Systolic Blood Pressure at Week 12 | Change from baseline in systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Systolic Blood Pressure at Week 16 | Change from baseline in systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Systolic Blood Pressure at Week 20 | Change from baseline in systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Systolic Blood Pressure at Week 26 | Change from baseline in systolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Diastolic Blood Pressure at Week 1 | Diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Diastolic Blood Pressure at Week 2 | Diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Diastolic Blood Pressure at Week 4 | Diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Diastolic Blood Pressure at Week 6 | Diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Diastolic Blood Pressure at Week 8 | Diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Diastolic Blood Pressure at Week 12 | Diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Diastolic Blood Pressure at Week 16 | Diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Diastolic Blood Pressure at Week 20 | Diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Diastolic Blood Pressure at Week 26 | Diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Diastolic Blood Pressure at Week 1 | Change from baseline in diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Diastolic Blood Pressure at Week 2 | Change from baseline in diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Diastolic Blood Pressure at Week 4 | Change from baseline in diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Diastolic Blood Pressure at Week 6 | Change from baseline in diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Diastolic Blood Pressure at Week 8 | Change from baseline in diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Diastolic Blood Pressure at Week 12 | Change from baseline in diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Diastolic Blood Pressure at Week 16 | Change from baseline in diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Diastolic Blood Pressure at Week 20 | Change from baseline in diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Diastolic Blood Pressure at Week 26 | Change from baseline in diastolic blood pressure (mm Hg) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Pulse at Week 1 | | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Pulse at Week 2 | | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Pulse at Week 4 | | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Pulse at Week 6 | | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Pulse at Week 8 | | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Pulse at Week 12 | | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Pulse at Week 16 | | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Pulse at Week 20 | | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Pulse at Week 26 | | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Pulse at Week 1 | Change from baseline in pulse (beats per minute) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline to Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Pulse at Week 2 | Change from baseline in pulse (beats per minute) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Pulse at Week 4 | Change from baseline in pulse (beats per minute) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Pulse at Week 6 | Change from baseline in pulse (beats per minute) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Pulse at Week 8 | Change from baseline in pulse (beats per minute) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Pulse at Week 12 | Change from baseline in pulse (beats per minute) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Pulse at Week 16 | Change from baseline in pulse (beats per minute) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Pulse at Week 20 | Change from baseline in pulse (beats per minute) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline to Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Pulse at Week 26 | Change from baseline in pulse (beats per minute) | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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. | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Number | | Percentage of Participants | | Week 6 or when withdrawn from study | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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. | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Number | | Percentage of Participants | | Week 6 or when withdrawn from study | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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. | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Number | | Percentage of Participants | | Week 6 or when withdrawn from study | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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. | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Number | | Percentage of Participants | | Week 6 or when withdrawn from study | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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. | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Number | | Percentage of Participants | | Week 6 or when withdrawn from study | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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. | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Number | | Percentage of Participants | | Week 6 or when withdrawn from study | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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. | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Number | | Percentage of Participants | | Week 6 or when withdrawn from study | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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. | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Number | | Percentage of Participants | | Week 6 or when withdrawn from study | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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. | Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment. | Posted | | Number | | Percentage of Participants | | Week 6 or when withdrawn from study | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Body Weight at Week 6 | Change from baseline in body weight | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Mean | Standard Deviation | pounds | | Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Body Weight at Week 12 | Change from baseline in body weight | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Mean | Standard Deviation | pounds | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| Secondary | Change From Baseline in Body Weight at Week 26 | Change from baseline in body weight | Analysis was based on the Full Analysis Set which included all randomized participants. | Posted | | Mean | Standard Deviation | pounds | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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 | Analysis was based on randomized participants verified continuously abstinent from smoking since the Week 2 visit. | Posted | | Mean | Standard Deviation | pounds | | Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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 | Analysis was based on randomized participants verified continuously abstinent from smoking since the Week 2 visit. | Posted | | Mean | Standard Deviation | pounds | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |
| 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 | Analysis was based on randomized participants verified continuously abstinent from smoking since the Week 2 visit. | Posted | | Mean | Standard Deviation | pounds | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions | | OG001 | Nicotine | Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions |
| |