Depression, Smoking Cessation
Conditions
Keywords
smoking, smoking cessation, smoking cessation in depressed subjects
Brief summary
Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.
Interventions
DRUGvarenicline
varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
DRUGplacebo
placebo tablets matched in appearance and dosage to varenicline tablets
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female cigarette smokers, 18-75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt * Smoked an average of at least 10 cigarettes per day during past year and over past month, and exhaled carbon monoxide (CO) \> 10 ppm at screening * Current or past diagnosis of MDD without psychotic features, either single or recurrent, using DSM IV TR based on clinical assessment and confirmed by SCID and at least one of the following: * On stable antidepressant treatment for MDD (stable dose for at least 2 months) * Major depressive episode, using DSM IV TR, in the past 2 years successfully treated
Exclusion criteria
* Current or past diagnosis of dementia, schizophrenia, schizoaffective disorder, or other psychotic disorder, bipolar I disorder, bipolar II disorder. * Subjects with antisocial, schizotypal, or any other personality disorder severe enough to compromise the subject's ability to comply with the study requirements.. * Current use of either bupropion or nortryptiline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) | Week 9 through Week 12 | Percentage of participants who reported no use of nicotine-containing products by answering No to the nicotine use inventory (NUI) questions: 'Has the participant smoked cigarettes' and 'Has the participant used other nicotine-containing products' in the last 7 days (Week 9) or since last study visit (Week 9 through 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Continuous Abstinence Rate (CAR) | Week 9 through Week 24, Week 9 through Week 52 | Percentage of participants who remained abstinent from the period defined as start of the primary endpoint (Week 9) through Week 24 and the end of follow-up (Week 52) by reporting no use of nicotine-containing products confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm. |
| Number of Participants With 7-day Point Prevalence (PP) of Abstinence | Weeks 12, 24, 52 | Number of participants reporting no use of nicotine-containing products in the last 7 days confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm. |
| Number of Participants With 4-Week Point Prevalence (PP) of Abstinence | Week 52 | Number of participants at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16 | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. Change: mean score at observation minus mean score at baseline. |
| Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events) | Baseline up to Week 16 | Adverse Event (AE):any untoward medical occurrence attributed to study drug in participant who received study drug.SAE:AE causing:death;initial/prolonged inpatient hospitalization;life-threatening experience(immediate risk of dying);persistent/significant disability/incapacity;congenital anomaly.Solicited AEs collected by semi-structured neuropsychiatric AEs interview inquiring about AEs:delusions,hallucinations,paranoia,psychosis,mania,panic,agitation,hostility,aggression,homicidal ideation. If participant had positive response,investigator determined if it met AE criteria. |
| Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU]) | C-SSRS assessed if participant experienced following: completed suicide (1), suicide attempt (2)(response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3)(Yes on preparatory acts or behavior), suicidal ideation (4)(Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(Yes on Has participant engaged in non-suicidal self-injurious behavior). |
| Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16 | The BIS-11 is a self-administered 30 items questionnaire to assess measure of impulsivity. Items are scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Total score range from 30 to 120. Barratt suggested that a total score of greater than or equal to 75 could indicate an impulse-control disorder, whereas a total score in the range of 70 to 75 could indicate pathological impulsivity. |
| Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52 | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement from baseline is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected |
| Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52 | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected |
| Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16 | Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: mean score at observation minus mean score at baseline. |
Countries
Bosnia and Herzegovina, Croatia, Germany, Hungary, Romania, Russia, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment. | 256 |
| Placebo Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment. | 269 |
| Total | 525 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 5 |
| Overall Study | Death | 2 | 0 |
| Overall Study | Did not meet entrance criteria | 0 | 1 |
| Overall Study | Lost to Follow-up | 12 | 13 |
| Overall Study | Other | 24 | 32 |
| Overall Study | Protocol Violation | 6 | 6 |
| Overall Study | Withdrawal by Subject | 31 | 33 |
Baseline characteristics
| Characteristic | Varenicline | Placebo | Total |
|---|---|---|---|
| Age, Customized 18 to 44 years | 106 participants | 98 participants | 204 participants |
| Age, Customized 45 to 64 years | 146 participants | 160 participants | 306 participants |
| Age, Customized Greater than or equal to 65 years | 4 participants | 11 participants | 15 participants |
| Sex: Female, Male Female | 159 Participants | 170 Participants | 329 Participants |
| Sex: Female, Male Male | 97 Participants | 99 Participants | 196 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 158 / 256 | 126 / 269 |
| serious Total, serious adverse events | 7 / 256 | 7 / 269 |
Outcome results
Primary
Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
Percentage of participants who reported no use of nicotine-containing products by answering No to the nicotine use inventory (NUI) questions: 'Has the participant smoked cigarettes' and 'Has the participant used other nicotine-containing products' in the last 7 days (Week 9) or since last study visit (Week 9 through 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm).
Time frame: Week 9 through Week 12
Population: All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) | 35.9 Percentage of participants |
| Placebo | Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) | 15.6 Percentage of participants |
Comparison: Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.p-value: <0.000195% CI: [2.16, 5.21]Regression, Logistic
Secondary
Number of Participants With 4-Week Point Prevalence (PP) of Abstinence
Number of participants at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Time frame: Week 52
Population: All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Number of Participants With 4-Week Point Prevalence (PP) of Abstinence | 70 participants |
| Placebo | Number of Participants With 4-Week Point Prevalence (PP) of Abstinence | 45 participants |
Comparison: Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.p-value: 0.002795% CI: [1.26, 3.08]Regression, Logistic
Secondary
Number of Participants With 7-day Point Prevalence (PP) of Abstinence
Number of participants reporting no use of nicotine-containing products in the last 7 days confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Time frame: Weeks 12, 24, 52
Population: All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With 7-day Point Prevalence (PP) of Abstinence | Week 12 | 118 participants |
| Varenicline | Number of Participants With 7-day Point Prevalence (PP) of Abstinence | Week 24 | 80 participants |
| Varenicline | Number of Participants With 7-day Point Prevalence (PP) of Abstinence | Week 52 | 73 participants |
| Placebo | Number of Participants With 7-day Point Prevalence (PP) of Abstinence | Week 12 | 54 participants |
| Placebo | Number of Participants With 7-day Point Prevalence (PP) of Abstinence | Week 24 | 49 participants |
| Placebo | Number of Participants With 7-day Point Prevalence (PP) of Abstinence | Week 52 | 47 participants |
Comparison: For Week 12, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.p-value: <0.000195% CI: [2.53, 5.78]Regression, Logistic
Comparison: For Week 24, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.p-value: 0.000495% CI: [1.4, 3.33]Regression, Logistic
Comparison: For Week 52, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.p-value: 0.00295% CI: [1.28, 3.08]Regression, Logistic
Secondary
Percentage of Participants With Continuous Abstinence Rate (CAR)
Percentage of participants who remained abstinent from the period defined as start of the primary endpoint (Week 9) through Week 24 and the end of follow-up (Week 52) by reporting no use of nicotine-containing products confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Time frame: Week 9 through Week 24, Week 9 through Week 52
Population: All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Percentage of Participants With Continuous Abstinence Rate (CAR) | Week 9 through Week 24 | 25.0 Percentage of participants |
| Varenicline | Percentage of Participants With Continuous Abstinence Rate (CAR) | Week 9 through Week 52 | 20.3 Percentage of participants |
| Placebo | Percentage of Participants With Continuous Abstinence Rate (CAR) | Week 9 through Week 24 | 12.3 Percentage of participants |
| Placebo | Percentage of Participants With Continuous Abstinence Rate (CAR) | Week 9 through Week 52 | 10.4 Percentage of participants |
Comparison: For Week 9 through 24, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.p-value: 0.000195% CI: [1.56, 4.1]Regression, Logistic
Comparison: For Week 9 through 52, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.p-value: 0.001195% CI: [1.4, 3.98]Regression, Logistic
Other Pre-specified
Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score
The BIS-11 is a self-administered 30 items questionnaire to assess measure of impulsivity. Items are scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Total score range from 30 to 120. Barratt suggested that a total score of greater than or equal to 75 could indicate an impulse-control disorder, whereas a total score in the range of 70 to 75 could indicate pathological impulsivity.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Population: Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Varenicline | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 4(n= 230, 246) | -1.0 Units on a scale | Standard Deviation 5.19 |
| Varenicline | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 8(n=219, 216) | -1.3 Units on a scale | Standard Deviation 5.81 |
| Varenicline | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 1(n=250,265) | -0.5 Units on a scale | Standard Deviation 4.36 |
| Varenicline | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 9(n=218, 215) | -1.5 Units on a scale | Standard Deviation 6.25 |
| Varenicline | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 5(n=228, 234) | -1.1 Units on a scale | Standard Deviation 5.27 |
| Varenicline | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 10(n=214, 211) | -1.5 Units on a scale | Standard Deviation 6.13 |
| Varenicline | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 3(n= 241, 249) | -1.0 Units on a scale | Standard Deviation 4.75 |
| Varenicline | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 11(n= 211, 205) | -1.6 Units on a scale | Standard Deviation 6.24 |
| Varenicline | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 6(n=224, 226) | -1.4 Units on a scale | Standard Deviation 5.28 |
| Varenicline | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 12(n= 210, 204) | -1.0 Units on a scale | Standard Deviation 6.55 |
| Varenicline | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 2(n= 244, 255) | -0.8 Units on a scale | Standard Deviation 4.73 |
| Varenicline | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 13(n= 211, 201) | -1.4 Units on a scale | Standard Deviation 6.52 |
| Varenicline | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 7(n=226, 227) | -1.6 Units on a scale | Standard Deviation 5.62 |
| Varenicline | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 16(n= 202, 196) | -1.4 Units on a scale | Standard Deviation 6.25 |
| Varenicline | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Baseline(n=256,269) | 65.1 Units on a scale | Standard Deviation 6.42 |
| Placebo | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 16(n= 202, 196) | -1.3 Units on a scale | Standard Deviation 6.85 |
| Placebo | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Baseline(n=256,269) | 64.2 Units on a scale | Standard Deviation 7.3 |
| Placebo | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 1(n=250,265) | -0.8 Units on a scale | Standard Deviation 4.26 |
| Placebo | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 2(n= 244, 255) | -1.1 Units on a scale | Standard Deviation 4.83 |
| Placebo | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 3(n= 241, 249) | -1.3 Units on a scale | Standard Deviation 4.81 |
| Placebo | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 4(n= 230, 246) | -1.2 Units on a scale | Standard Deviation 4.95 |
| Placebo | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 5(n=228, 234) | -1.1 Units on a scale | Standard Deviation 5.39 |
| Placebo | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 6(n=224, 226) | -1.2 Units on a scale | Standard Deviation 5.43 |
| Placebo | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 7(n=226, 227) | -1.3 Units on a scale | Standard Deviation 6.08 |
| Placebo | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 8(n=219, 216) | -1.2 Units on a scale | Standard Deviation 6.54 |
| Placebo | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 9(n=218, 215) | -1.4 Units on a scale | Standard Deviation 6.24 |
| Placebo | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 10(n=214, 211) | -1.7 Units on a scale | Standard Deviation 6.94 |
| Placebo | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 11(n= 211, 205) | -1.5 Units on a scale | Standard Deviation 6.78 |
| Placebo | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 12(n= 210, 204) | -1.4 Units on a scale | Standard Deviation 7.31 |
| Placebo | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score | Change at Week 13(n= 211, 201) | -1.1 Units on a scale | Standard Deviation 7 |
Other Pre-specified
Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. Change: mean score at observation minus mean score at baseline.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Population: Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Varenicline | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 16(n= 202, 197) | -2.7 Units on a scale | Standard Deviation 4.67 |
| Varenicline | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Baseline(n=256,269) | 6.1 Units on a scale | Standard Deviation 5.23 |
| Varenicline | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 1(n=250,265) | -0.5 Units on a scale | Standard Deviation 2.54 |
| Varenicline | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 2(n= 245, 255) | -0.7 Units on a scale | Standard Deviation 3.98 |
| Varenicline | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 3(n= 241, 249) | -1.3 Units on a scale | Standard Deviation 3.41 |
| Varenicline | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 4(n= 230, 246) | -1.6 Units on a scale | Standard Deviation 3.72 |
| Varenicline | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 5(n=228, 235) | -1.6 Units on a scale | Standard Deviation 4.05 |
| Varenicline | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 6(n=224, 227) | -1.7 Units on a scale | Standard Deviation 4.03 |
| Varenicline | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 7(n=226, 227) | -2.0 Units on a scale | Standard Deviation 4.4 |
| Varenicline | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 8(n=221, 218) | -1.9 Units on a scale | Standard Deviation 4.65 |
| Varenicline | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 9(n=218, 216) | -2.0 Units on a scale | Standard Deviation 4.4 |
| Varenicline | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 10(n=214, 212) | -2.2 Units on a scale | Standard Deviation 4.24 |
| Varenicline | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 11(n= 211, 206) | -2.3 Units on a scale | Standard Deviation 4.48 |
| Varenicline | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 12(n= 210, 205) | -2.3 Units on a scale | Standard Deviation 4.27 |
| Varenicline | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 13(n= 211, 201) | -2.4 Units on a scale | Standard Deviation 4.49 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 16(n= 202, 197) | -2.5 Units on a scale | Standard Deviation 4.28 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 7(n=226, 227) | -1.8 Units on a scale | Standard Deviation 4.32 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Baseline(n=256,269) | 6.4 Units on a scale | Standard Deviation 5.17 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 11(n= 211, 206) | -2.1 Units on a scale | Standard Deviation 4.31 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 1(n=250,265) | -0.7 Units on a scale | Standard Deviation 3.15 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 8(n=221, 218) | -1.9 Units on a scale | Standard Deviation 4.1 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 2(n= 245, 255) | -0.5 Units on a scale | Standard Deviation 3.79 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 13(n= 211, 201) | -2.7 Units on a scale | Standard Deviation 4.34 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 3(n= 241, 249) | -1.2 Units on a scale | Standard Deviation 3.68 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 9(n=218, 216) | -1.9 Units on a scale | Standard Deviation 3.94 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 4(n= 230, 246) | -1.2 Units on a scale | Standard Deviation 3.87 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 12(n= 210, 205) | -2.4 Units on a scale | Standard Deviation 4.47 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 5(n=228, 235) | -1.6 Units on a scale | Standard Deviation 4 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 10(n=214, 212) | -2.0 Units on a scale | Standard Deviation 4.12 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score | Change at Week 6(n=224, 227) | -1.6 Units on a scale | Standard Deviation 4 |
Other Pre-specified
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: mean score at observation minus mean score at baseline.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Population: Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Varenicline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 4(n= 230, 246) | -2.2 Units on a scale | Standard Deviation 5.62 |
| Varenicline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 8(n=221, 218) | -2.7 Units on a scale | Standard Deviation 6.51 |
| Varenicline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 1(n=250,265) | -1.2 Units on a scale | Standard Deviation 3.95 |
| Varenicline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 9(n=218, 216) | -2.9 Units on a scale | Standard Deviation 6.11 |
| Varenicline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 5(n=228, 235) | -2.1 Units on a scale | Standard Deviation 6.01 |
| Varenicline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 10(n=214, 212) | -2.9 Units on a scale | Standard Deviation 6.21 |
| Varenicline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 3(n= 241, 249) | -1.9 Units on a scale | Standard Deviation 5.19 |
| Varenicline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 11(n= 211, 206) | -3.2 Units on a scale | Standard Deviation 6.3 |
| Varenicline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 6(n=224, 227) | -2.2 Units on a scale | Standard Deviation 6.15 |
| Varenicline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 12(n= 210, 205) | -3.4 Units on a scale | Standard Deviation 6.2 |
| Varenicline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 2(n= 245, 255) | -1.0 Units on a scale | Standard Deviation 6.06 |
| Varenicline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 13(n= 211, 201) | -3.0 Units on a scale | Standard Deviation 6.39 |
| Varenicline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 7(n=226, 227) | -2.3 Units on a scale | Standard Deviation 6.57 |
| Varenicline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 16(n= 202, 197) | -3.1 Units on a scale | Standard Deviation 6.36 |
| Varenicline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Baseline(n=256,269) | 7.6 Units on a scale | Standard Deviation 7.38 |
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 16(n= 202, 197) | -3.2 Units on a scale | Standard Deviation 6.61 |
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Baseline(n=256,269) | 7.9 Units on a scale | Standard Deviation 7.51 |
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 1(n=250,265) | -0.6 Units on a scale | Standard Deviation 4.17 |
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 2(n= 245, 255) | -1.1 Units on a scale | Standard Deviation 5.33 |
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 3(n= 241, 249) | -1.8 Units on a scale | Standard Deviation 4.96 |
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 4(n= 230, 246) | -1.5 Units on a scale | Standard Deviation 5.96 |
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 5(n=228, 235) | -2.3 Units on a scale | Standard Deviation 6.09 |
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 6(n=224, 227) | -2.3 Units on a scale | Standard Deviation 5.84 |
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 7(n=226, 227) | -2.4 Units on a scale | Standard Deviation 5.94 |
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 8(n=221, 218) | -2.6 Units on a scale | Standard Deviation 6.02 |
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 9(n=218, 216) | -2.5 Units on a scale | Standard Deviation 6.55 |
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 10(n=214, 212) | -2.8 Units on a scale | Standard Deviation 6.15 |
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 11(n= 211, 206) | -2.9 Units on a scale | Standard Deviation 6.13 |
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 12(n= 210, 205) | -3.2 Units on a scale | Standard Deviation 6.34 |
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Change at Week 13(n= 211, 201) | -3.6 Units on a scale | Standard Deviation 5.88 |
Other Pre-specified
Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)
Adverse Event (AE):any untoward medical occurrence attributed to study drug in participant who received study drug.SAE:AE causing:death;initial/prolonged inpatient hospitalization;life-threatening experience(immediate risk of dying);persistent/significant disability/incapacity;congenital anomaly.Solicited AEs collected by semi-structured neuropsychiatric AEs interview inquiring about AEs:delusions,hallucinations,paranoia,psychosis,mania,panic,agitation,hostility,aggression,homicidal ideation. If participant had positive response,investigator determined if it met AE criteria.
Time frame: Baseline up to Week 16
Population: Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events) | 185 participants |
| Placebo | Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events) | 180 participants |
Other Pre-specified
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement from baseline is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected
Time frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
Population: Safety analysis population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 5: no change(n=227,233) | 146 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 10: very much improved(n=212,211) | 20 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 3: minimally improved(n=241,248) | 42 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 10: much improved(n=212,211) | 21 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 5: minimally worse(n=227,233) | 19 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 10: minimally improved(n=212,211) | 30 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 1: minimally worse(n=250,263) | 16 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 10: no change(n=212,211) | 124 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 5: much worse(n=227,233) | 1 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 10: minimally worse(n=212,211) | 16 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 3: no change(n=241,248) | 146 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 10: much worse(n=212,211) | 1 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 6: very much improved(n=224,226) | 11 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 11: very much improved(n=211,205) | 23 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 2: minimally improved(n=244,255) | 33 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 11: much improved(n=211,205) | 17 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 6: much improved(n=224,226) | 20 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 11: minimally improved(n=211,205) | 38 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 3: minimally worse(n=241,248) | 26 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 11: no change(n=211,205) | 120 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 6: minimally improved(n=224,226) | 39 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 11: minimally worse(n=211,205) | 13 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 1: much improved(n=250,263) | 12 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 11: much worse(n=211,205) | 0 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 6: no change(n=224,226) | 139 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 12: very much improved(n=210,204) | 19 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 3: much worse(n=241,248) | 0 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 12: much improved(n=210,204) | 19 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 6: minimally worse(n=224,226) | 13 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 12: minimally improved(n=210,204) | 34 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 2: no change(n=244,255) | 159 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 12: no change(n=210,204) | 127 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 6: much worse(n=224,226) | 2 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 12: minimally worse(n=210,204) | 11 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 4: very much improved(n=230,245) | 8 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 13: very much improved(n=211,200) | 18 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 7: very much improved(n=226,226) | 19 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 13: much improved(n=211,200) | 19 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 1: much worse(n=250,263) | 1 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 13: minimally improved(n=211,200) | 34 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 7: much improved(n=226,226) | 23 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 13: no change(n=211,200) | 127 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 4: much improved(n=230,245) | 18 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 13: minimally worse(n=211,200) | 12 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 7: minimally improved(n=226,226) | 32 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 13: much worse(n=211,200) | 1 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 2: minimally worse(n=244,255) | 27 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 16: very much improved(n=203,199) | 17 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 7: no change(n=226,226) | 136 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 16: much improved(n=203,199) | 27 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 4: minimally improved(n=230,245) | 35 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 16: minimally improved(n=203,199) | 26 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 7: minimally worse(n=226,226) | 14 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 16: no change(n=203,199) | 119 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 1: no change(n=250,263) | 189 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 16: minimally worse(n=203,199) | 14 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 7: much worse(n=226,226) | 2 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 16: much worse(n=203,199) | 0 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 4: no change(n=230,245) | 152 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 24: very much improved(n=196,193) | 17 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 8: very much improved(n=221,217) | 19 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 24: much improved(n=196,193) | 17 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 2: much worse(n=244,255) | 5 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 24: minimally improved(n=196,193) | 24 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 8: much improved(n=221,217) | 18 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 24: no change(n=196,193) | 127 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 4: minimally worse(n=230,245) | 15 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 24: minimally worse(n=196,193) | 10 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 8: minimally improved(n=221,217) | 37 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 24: much worse(n=196,193) | 1 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 2: very much improved(n=244,255) | 2 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 32: very much improved(n=188,188) | 15 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 8: no change(n=221,217) | 131 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 32: much improved(n=188,188) | 19 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 4: much worse(n=230,245) | 2 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 32: minimally improved(n=188,188) | 27 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 8: minimally worse(n=221,217) | 15 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 32: no change(n=188,188) | 118 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 3: very much improved(n=241,248) | 10 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 32: minimally worse(n=188,188) | 9 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 8: much worse(n=221,217) | 0 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 32: much worse(n=188,188) | 0 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 5: very much improved(n=227,233) | 13 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 40: very much improved(n=180,182) | 10 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 8: very much worse(n=221,217) | 1 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 40: much improved(n=180,182) | 23 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 1: minimally improved(n=250,263) | 31 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 40: minimally improved(n=180,182) | 23 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 9: very much improved(n=218,214) | 19 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 40: no change(n=180,182) | 117 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 5: much improved(n=227,233) | 14 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 40: minimally worse(n=180,182) | 6 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 9: much improved(n=218,214) | 19 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 40: much worse(n=180,182) | 0 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 3: much improved(n=241,248) | 17 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 40: very much worse(n=180,182) | 1 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 9: minimally improved(n=218,214) | 36 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 52: very much improved(n=178,180) | 20 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 5: minimally improved(n=227,233) | 34 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 52: much improved(n=178,180) | 20 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 9: no change(n=218,214) | 129 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 52: minimally improved(n=178,180) | 25 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 2: much improved(n=244,255) | 18 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 52: no change(n=178,180) | 110 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 9: minimally worse(n=218,214) | 15 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 52: minimally worse(n=178,180) | 3 participants |
| Varenicline | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 1: very much improved(n=250,263) | 1 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 52: minimally worse(n=178,180) | 7 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 1: very much improved(n=250,263) | 2 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 1: much improved(n=250,263) | 6 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 1: minimally improved(n=250,263) | 21 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 1: no change(n=250,263) | 222 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 1: minimally worse(n=250,263) | 11 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 1: much worse(n=250,263) | 1 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 2: very much improved(n=244,255) | 1 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 2: much improved(n=244,255) | 12 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 2: minimally improved(n=244,255) | 38 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 2: no change(n=244,255) | 181 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 2: minimally worse(n=244,255) | 21 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 2: much worse(n=244,255) | 2 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 3: very much improved(n=241,248) | 4 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 3: much improved(n=241,248) | 14 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 3: minimally improved(n=241,248) | 45 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 3: no change(n=241,248) | 165 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 3: minimally worse(n=241,248) | 17 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 3: much worse(n=241,248) | 3 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 4: very much improved(n=230,245) | 6 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 4: much improved(n=230,245) | 12 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 4: minimally improved(n=230,245) | 51 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 4: no change(n=230,245) | 154 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 4: minimally worse(n=230,245) | 19 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 4: much worse(n=230,245) | 3 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 5: very much improved(n=227,233) | 9 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 5: much improved(n=227,233) | 11 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 5: minimally improved(n=227,233) | 46 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 5: no change(n=227,233) | 151 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 5: minimally worse(n=227,233) | 14 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 5: much worse(n=227,233) | 2 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 6: very much improved(n=224,226) | 6 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 6: much improved(n=224,226) | 14 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 6: minimally improved(n=224,226) | 41 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 6: no change(n=224,226) | 148 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 6: minimally worse(n=224,226) | 17 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 6: much worse(n=224,226) | 0 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 7: very much improved(n=226,226) | 9 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 7: much improved(n=226,226) | 18 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 7: minimally improved(n=226,226) | 34 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 7: no change(n=226,226) | 150 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 7: minimally worse(n=226,226) | 13 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 7: much worse(n=226,226) | 2 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 8: very much improved(n=221,217) | 12 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 8: much improved(n=221,217) | 15 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 8: minimally improved(n=221,217) | 40 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 8: no change(n=221,217) | 139 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 8: minimally worse(n=221,217) | 10 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 8: much worse(n=221,217) | 1 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 8: very much worse(n=221,217) | 0 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 9: very much improved(n=218,214) | 13 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 9: much improved(n=218,214) | 16 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 9: minimally improved(n=218,214) | 31 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 9: no change(n=218,214) | 141 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 9: minimally worse(n=218,214) | 13 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 10: very much improved(n=212,211) | 13 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 10: much improved(n=212,211) | 18 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 10: minimally improved(n=212,211) | 35 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 10: no change(n=212,211) | 133 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 10: minimally worse(n=212,211) | 11 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 10: much worse(n=212,211) | 1 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 11: very much improved(n=211,205) | 15 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 11: much improved(n=211,205) | 14 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 11: minimally improved(n=211,205) | 35 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 11: no change(n=211,205) | 129 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 11: minimally worse(n=211,205) | 10 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 11: much worse(n=211,205) | 2 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 12: very much improved(n=210,204) | 17 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 12: much improved(n=210,204) | 13 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 12: minimally improved(n=210,204) | 39 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 12: no change(n=210,204) | 124 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 12: minimally worse(n=210,204) | 11 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 13: very much improved(n=211,200) | 16 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 13: much improved(n=211,200) | 13 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 13: minimally improved(n=211,200) | 40 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 13: no change(n=211,200) | 121 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 13: minimally worse(n=211,200) | 10 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 13: much worse(n=211,200) | 0 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 16: very much improved(n=203,199) | 15 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 16: much improved(n=203,199) | 16 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 16: minimally improved(n=203,199) | 33 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 16: no change(n=203,199) | 119 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 16: minimally worse(n=203,199) | 12 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 16: much worse(n=203,199) | 4 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 24: very much improved(n=196,193) | 13 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 24: much improved(n=196,193) | 18 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 24: minimally improved(n=196,193) | 31 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 24: no change(n=196,193) | 125 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 24: minimally worse(n=196,193) | 6 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 24: much worse(n=196,193) | 0 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 32: very much improved(n=188,188) | 19 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 32: much improved(n=188,188) | 21 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 32: minimally improved(n=188,188) | 31 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 32: no change(n=188,188) | 113 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 32: minimally worse(n=188,188) | 3 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 32: much worse(n=188,188) | 1 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 40: very much improved(n=180,182) | 17 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 40: much improved(n=180,182) | 15 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 40: minimally improved(n=180,182) | 32 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 40: no change(n=180,182) | 109 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 40: minimally worse(n=180,182) | 7 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 40: much worse(n=180,182) | 2 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 40: very much worse(n=180,182) | 0 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 52: very much improved(n=178,180) | 22 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 52: much improved(n=178,180) | 13 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 52: minimally improved(n=178,180) | 26 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Week 52: no change(n=178,180) | 112 participants |
Other Pre-specified
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS assessed if participant experienced following: completed suicide (1), suicide attempt (2)(response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3)(Yes on preparatory acts or behavior), suicidal ideation (4)(Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(Yes on Has participant engaged in non-suicidal self-injurious behavior).
Time frame: Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])
Population: Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,4 | 15 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,4: with specific plan and intent | 0 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,Suicidal Behavior or/and Ideation | 15 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,Suicidal Behavior or/and Ideation | 13 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,4: wish to be dead | 15 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,1 | 1 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline,4: wish to be dead | 6 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,4 | 12 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,4: non-specific active suicidal thoughts | 4 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,4: wish to be dead | 11 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,2 | 0 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,4: non-specific active suicidal thoughts | 5 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,4: with any methods,without intent to act | 2 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,4: with any methods,without intent to act | 2 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline,4 | 6 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,4: with some intent,without specific plan | 1 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,4: with some intent,without specific plan. | 0 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,7 | 1 participants |
| Varenicline | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline,Suicidal Behavior or/and Ideation | 6 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,7 | 1 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline,Suicidal Behavior or/and Ideation | 1 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline,4 | 1 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline,4: wish to be dead | 1 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,Suicidal Behavior or/and Ideation | 20 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,2 | 1 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,4 | 19 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,4: wish to be dead | 18 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,4: non-specific active suicidal thoughts | 7 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,4: with any methods,without intent to act | 5 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,4: with some intent,without specific plan. | 3 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | TE,4: with specific plan and intent | 1 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,Suicidal Behavior or/and Ideation | 12 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,1 | 0 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,4 | 12 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,4: wish to be dead | 12 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,4: non-specific active suicidal thoughts | 3 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,4: with any methods,without intent to act | 2 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | FU,4: with some intent,without specific plan | 1 participants |
Other Pre-specified
Number of Participants With Clinical Global Impression - Severity (CGI-S) Score
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
Population: Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. Here, the 'n' is signifying those participants who were evaluable for this measure at the specific categories for each arm group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 9:Moderately (n=218,213) | 8 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 1:Mildly (n=250,263) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 9:Moderately (n=218,213) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 5:Mildly (n=227,232) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 9:Markedly (n=218,213) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 3:Borderline (n=241,247) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 9:Markedly (n=218,213) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 5:Mildly (n=227,232) | 6 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 10:Normal (n=212,210) | 88 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline: Moderately; Week 2:Normal (n=244,254) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 10:Normal (n=212,210) | 20 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 5:Mildly (n=227,232) | 36 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 10:Normal (n=212,210) | 13 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 3:Borderline (n=241,247) | 16 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 10:Normal (n=212,210) | 7 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 5:Mildly (n=227,232) | 11 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 10:Borderline (n=212,210) | 5 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 1:Borderline (n=250,263) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 10:Borderline (n=212,210 | 14 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 5:Mildly (n=227,232) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 10:Borderline (n=212,210) | 6 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 3:Borderline (n=241,247) | 8 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 10:Borderline(n=212,210) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 5:Moderately (n=227,232) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 10:Borderline(n=212,210) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 2:Borderline (n=244,254) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 10:Mildly (n=212,210) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 5:Moderately (n=227,232) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 10:Mildly (n=212,210) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 3:Borderline (n=241,247) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 10:Mildly (n=212,210) | 29 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 5:Moderately (n=227,232) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 10:Mildly (n=212,210) | 8 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 1:Mildly (n=250,263) | 46 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 10:Moderately (n=212,210) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 5:Moderately (n=227,232) | 12 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 10:Moderately (n=212,210) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 3:Mildly (n=241,247) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 10:Moderately(n=212,210) | 9 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 5:Moderately (n=227,232) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 10:Moderately (n=212,210) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 3:Mildly (n=241,247) | 6 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 10:Markedly (n=212,210) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 5:Markedly (n=227,232) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 11:Normal (n=211,205) | 90 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 2:Borderline (n=244,254) | 22 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 11:Normal (n=211,205) | 23 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 6:Normal (n=224,225) | 96 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 11:Normal (n=211,205) | 13 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 3:Mildly (n=241,247) | 42 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 11:Normal (n=211,205) | 7 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 6:Normal (n=224,225) | 22 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 11:Normal (n=211,205) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 1:Normal (n=250,263) | 105 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 11:Borderline (n=211,205) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 6:Normal (n=224,225) | 10 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 11:Borderline(n=211,205) | 10 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 3:Mildly (n=241,247) | 10 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 11:Borderline (n=211,205) | 6 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 6:Normal (n=224,225) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 11:Borderline(n=211,205) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 2:Borderline (n=244,254) | 10 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 11:Borderline (n=211,205) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 6:Borderline (n=224,225) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 11:Mildly (n=211,205) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 3:Mildly (n=241,247) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 11:Mildly (n=211,205) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 6:Borderline (n=224,225) | 11 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 11:Mildly (n=211,205) | 30 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 1:Mildly (n=250,263) | 6 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 11:Mildly (n=211,205) | 9 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 6:Borderline (n=224,225) | 6 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 11:Moderately (n=211,205) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 3:Moderately (n=241,247) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 11:Moderately (n=211,205) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 6:Borderline (n=224,225) | 5 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 11:Moderately(n=211,205) | 8 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 2:Borderline (n=244,254) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 11:Moderately (n=211,205) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 6:Mildly (n=224,225) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 11:Markedly (n=211,205) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 3:Moderately (n=241,247) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 12:Normal (n=210,203) | 89 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 6:Mildly (n=224,225) | 5 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 12:Normal (n=210,203) | 23 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 1:Borderline (n=250,263) | 31 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 12:Normal (n=210,203) | 13 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 6:Mildly (n=224,225) | 38 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 12:Normal (n=210,203) | 6 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 3:Moderately (n=241,247) | 19 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 12:Normal (n=210,203) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 6:Mildly (n=224,225) | 8 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 12:Borderline (n=210,203) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 2:Mildly (n=244,254) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 12:Borderline(n=210,203) | 12 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 6:Mildly (n=224,225) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 12:Borderline (n=210,203) | 6 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 3:Moderately (n=241,247) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 12:Borderline(n=210,203) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 6:Moderately (n=224,225) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 12:Borderline (n=210,203) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 1:Moderately (n=250,263) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 12:Mildly (n=210,203) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 6:Moderately (n=224,225) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 12:Mildly (n=210,203) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 3:Markedly (n=241,247) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 12:Mildly (n=210,203) | 30 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 6:Moderately (n=224,225) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 12:Mildly (n=210,203) | 9 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 2:Mildly (n=244,254) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 12:Moderately(n=210,203) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 6:Moderately (n=224,225) | 10 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 12:Moderately (n=210,203) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 3:Markedly (n=241,247) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 12:Moderately(n=210,203) | 8 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 6:Markedly (n=224,225) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 12:Moderately(n=210,203) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 1:Normal (n=250,263) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 12:Markedly(n=210,203) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 6:Markedly (n=224,225) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 13:Normal (n=211,199) | 92 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 4:Normal (n=230,244) | 101 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 13:Normal (n=211,199) | 22 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 7:Normal (n=226,225) | 93 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 13:Normal (n=211,199) | 13 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 2:Mildly (n=244,254) | 40 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 13:Normal (n=211,199) | 6 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 7:Normal (n=226,225) | 23 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 13:Normal (n=211,199) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 4:Normal (n=230,244) | 17 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 13:Borderline (n=211,199) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 7:Normal (n=226,225) | 14 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 13:Borderline(n=211,199) | 11 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 1:Moderately (n=250,263) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 13:Borderline (n=211,199) | 7 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 7:Normal (n=226,225) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 13:Borderline(n=211,199) | 5 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 4:Normal (n=230,244) | 7 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 13:Borderline(n=211,199) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 7:Borderline (n=226,225) | 5 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 13:Mildly (n=211,199) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 2:Mildly (n=244,254) | 10 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 13:Mildly (n=211,199) | 30 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 7:Borderline (n=226,225) | 13 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 13:Mildly (n=211,199) | 9 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 4:Normal (n=230,244) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 13:Moderately (n=211,199) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 7:Borderline (n=226,225) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 13:Moderately(n=211,199) | 7 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 1:Borderline (n=250,263) | 9 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 13:Moderately(n=211,199) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 7:Borderline (n=226,225) | 5 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 13:Markedly (n=211,199) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 4:Borderline (n=230,244) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 16:Normal (n=203,198) | 91 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 7:Borderline (n=226,225) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 16:Normal (n=203,198) | 19 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 2:Mildly (n=244,254) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 16:Normal (n=203,198) | 14 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 7:Mildly (n=226,225) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 16:Normal (n=203,198) | 7 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 4:Borderline (n=230,244) | 17 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 16:Normal (n=203,198) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 7:Mildly (n=226,225) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 16:Borderline (n=203,198) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 1:Moderately (n=250,263) | 28 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 7:Mildly (n=226,225) | 36 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 16:Borderline(n=203,198) | 11 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 4:Borderline (n=230,244) | 8 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 16:Borderline (n=203,198) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 7:Mildly (n=226,225) | 10 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 16:Borderline(n=203,198) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 2:Moderately (n=244,254) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 16:Borderline (n=203,198) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 7:Mildly (n=226,225) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 16:Mildly (n=203,198) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 4:Borderline (n=230,244) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 16:Mildly (n=203,198) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 7:Moderately (n=226,225) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 16:Mildly (n=203,198) | 30 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 52:Moderately(n=178,179) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 16:Mildly (n=203,198) | 11 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 7:Moderately (n=226,225) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 16:Moderately(n=203,198) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 4:Mildly (n=230,244) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 16:Moderately (n=203,198) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 7:Moderately (n=226,225) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 16:Moderately(n=203,198) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 2:Moderately (n=244,254) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 16:Moderately (n=203,198) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 7:Moderately (n=226,225) | 10 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 16:Markedly (n=203,198) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 4:Mildly (n=230,244) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 24:Normal (n=196,192) | 88 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 7:Moderately (n=226,225) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 24:Normal (n=196,192) | 18 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 1:Moderately (n=250,263) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 7:Markedly (n=226,225) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 24:Normal (n=196,192) | 15 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 4:Mildly (n=230,244) | 39 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 24:Normal (n=196,192) | 5 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 8:Normal (n=221,216) | 92 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 24:Normal (n=196,192) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 24:Borderline (n=196,192) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 2:Moderately (n=244,254) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 24:Borderline(n=196,192) | 13 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 8:Normal (n=221,216) | 21 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 24:Borderline (n=196,192) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 4:Mildly (n=230,244) | 11 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 24:Borderline(n=196,192) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 8:Normal (n=221,216) | 12 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 24:Borderline (n=196,192) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 1:Borderline (n=250,263) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 24:Mildly (n=196,192) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 8:Normal (n=221,216) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 24:Mildly (n=196,192) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 4:Mildly (n=230,244) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 24:Mildly (n=196,192) | 27 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 8:Borderline (n=221,216) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 24:Mildly (n=196,192) | 8 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 2:Moderately (n=244,254) | 20 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 24:Moderately (n=196,192) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 8:Borderline (n=221,216) | 14 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 24:Moderately(n=196,192) | 7 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 4:Moderately (n=230,244) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 24:Moderately (n=196,192) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 8:Borderline (n=221,216) | 6 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 24:Markedly (n=196,192) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 1:Markedly (n=250,263) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 32:Normal (n=188,187) | 82 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 32:Normal (n=188,187) | 16 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 8:Borderline (n=221,216) | 7 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 32:Normal (n=188,187) | 10 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 4:Moderately (n=230,244) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 32:Normal (n=188,187) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 8:Borderline (n=221,216) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 32:Normal (n=188,187) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 2:Moderately (n=244,254) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 32:Borderline (n=188,187) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 8:Mildly (n=221,216) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 32:Borderline(n=188,187) | 12 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 4:Moderately (n=230,244) | 12 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 32:Borderline (n=188,187) | 9 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 8:Mildly (n=221,216) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 32:Borderline(n=188,187) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 1:Normal (n=250,263) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 32:Borderline (n=188,187) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 8:Mildly (n=221,216) | 32 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 32:Mildly (n=188,187) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 4:Moderately (n=230,244) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 32:Mildly (n=188,187) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 8:Mildly (n=221,216) | 9 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 32:Mildly (n=188,187) | 28 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline: Moderately; Week 2:Markedly (n=244,254) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 32:Mildly (n=188,187) | 8 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 8:Mildly (n=221,216) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 32:Mildly (n=188,187) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 4:Markedly (n=230,244) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 32:Moderately (n=188,187) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 8:Moderately (n=221,216) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 32:Moderately(n=188,187) | 7 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 2:Normal (n=244,254) | 102 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 32:Markedly (n=188,187) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 8:Moderately (n=221,216) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 32:Markedly (n=188,187) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 4:Markedly (n=230,244) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 40:Normal (n=180,181) | 81 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 8:Moderately (n=221,216) | 9 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 40:Normal (n=180,181) | 17 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 2:Markedly (n=244,254) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 40:Normal (n=180,181) | 11 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 8:Moderately (n=221,216) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 40:Normal (n=180,181) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 4:Markedly (n=230,244) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 40:Normal (n=180,181) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 8:Markedly (n=221,216) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 40:Borderline (n=180,181) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 1:Mildly (n=250,263) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 40:Borderline(n=180,181) | 9 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 8:Markedly (n=221,216) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 40:Borderline (n=180,181) | 8 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 5:Normal (n=227,232) | 98 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 40:Borderline(n=180,181) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 9:Normal (n=218,213) | 91 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 40:Borderline (n=180,181) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 3:Normal (n=241,247) | 101 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 40:Mildly (n=180,181) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 9:Normal (n=218,213) | 22 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 40:Mildly (n=180,181) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 5:Normal (n=227,232) | 19 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 40:Mildly (n=180,181) | 25 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 9:Normal (n=218,213) | 11 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 40:Mildly (n=180,181) | 11 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 2:Normal (n=244,254) | 13 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 40:Mildly (n=180,181) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 9:Normal (n=218,213) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 40:Moderately (n=180,181) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 5:Normal (n=227,232) | 8 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 40:Moderately (n=180,181) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 9:Borderline (n=218,213) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 40:Moderately(n=180,181) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 3:Normal (n=241,247) | 18 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 40:Markedly (n=180,181) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 9:Borderline (n=218,213) | 13 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 52:Normal (n=178,179) | 81 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 5:Normal (n=227,232) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 52:Normal (n=178,179) | 19 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 9:Borderline (n=218,213) | 6 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 52:Normal (n=178,179) | 12 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 1:Normal (n=250,263) | 7 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 52:Normal (n=178,179) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 9:Borderline (n=218,213) | 6 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 52:Normal (n=178,179) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 52:Borderline (n=178,179) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 5:Borderline (n=227,232) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 52:Borderline(n=178,179) | 8 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 9:Borderline (n=218,213) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 52:Borderline (n=178,179) | 8 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 3:Normal (n=241,247) | 6 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 52:Borderline(n=178,179) | 4 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 9:Mildly (n=218,213) | 3 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 52:Borderline (n=178,179) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 5:Borderline (n=227,232) | 13 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 52:Mildly (n=178,179) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 9:Mildly (n=218,213) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 52:Mildly (n=178,179) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 2:Normal (n=244,254) | 5 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 52:Mildly (n=178,179) | 24 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 9:Mildly (n=218,213) | 34 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 52:Mildly (n=178,179) | 8 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 5:Borderline (n=227,232) | 8 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 52:Moderately (n=178,179) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 9:Mildly (n=218,213) | 10 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 3:Normal (n=241,247) | 2 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 52:Moderately (n=178,179) | 0 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 9:Moderately (n=218,213) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 52:Markedly (n=178,179) | 1 participants |
| Varenicline | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 5:Borderline (n=227,232) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 52:Markedly (n=178,179) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 3:Mildly (n=241,247) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 1:Normal (n=250,263) | 100 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 1:Normal (n=250,263) | 8 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 1:Normal (n=250,263) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 1:Normal (n=250,263) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 1:Borderline (n=250,263) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 1:Borderline (n=250,263) | 42 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 1:Borderline (n=250,263) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 1:Borderline (n=250,263) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 1:Mildly (n=250,263) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 1:Mildly (n=250,263) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 1:Mildly (n=250,263) | 56 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 1:Mildly (n=250,263) | 9 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 1:Moderately (n=250,263) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 1:Moderately (n=250,263) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 1:Moderately (n=250,263) | 30 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 1:Moderately (n=250,263) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 1:Markedly (n=250,263) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 2:Normal (n=244,254) | 96 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 2:Normal (n=244,254) | 12 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 2:Normal (n=244,254) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline: Moderately; Week 2:Normal (n=244,254) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 2:Borderline (n=244,254) | 5 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 2:Borderline (n=244,254) | 37 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 2:Borderline (n=244,254) | 7 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 2:Borderline (n=244,254) | 4 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 2:Mildly (n=244,254) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 2:Mildly (n=244,254) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 2:Mildly (n=244,254) | 48 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 2:Mildly (n=244,254) | 12 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 2:Mildly (n=244,254) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 2:Moderately (n=244,254) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 2:Moderately (n=244,254) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 2:Moderately (n=244,254) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 2:Moderately (n=244,254) | 24 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 2:Moderately (n=244,254) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline: Moderately; Week 2:Markedly (n=244,254) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 2:Markedly (n=244,254) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 3:Normal (n=241,247) | 95 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 3:Normal (n=241,247) | 16 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 3:Normal (n=241,247) | 4 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 3:Normal (n=241,247) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 3:Borderline (n=241,247) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 3:Borderline (n=241,247) | 34 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 3:Borderline (n=241,247) | 7 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 3:Borderline (n=241,247) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 3:Mildly (n=241,247) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 3:Mildly (n=241,247) | 42 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 3:Mildly (n=241,247) | 17 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 3:Mildly (n=241,247) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 3:Moderately (n=241,247) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 3:Moderately (n=241,247) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 3:Moderately (n=241,247) | 20 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 3:Moderately (n=241,247) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 3:Markedly (n=241,247) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 3:Markedly (n=241,247) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 4:Normal (n=230,244) | 92 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 4:Normal (n=230,244) | 17 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 4:Normal (n=230,244) | 5 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 4:Normal (n=230,244) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 4:Borderline (n=230,244) | 5 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 4:Borderline (n=230,244) | 27 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 4:Borderline (n=230,244) | 7 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 4:Borderline (n=230,244) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 4:Mildly (n=230,244) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 4:Mildly (n=230,244) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 4:Mildly (n=230,244) | 43 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 4:Mildly (n=230,244) | 15 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 4:Mildly (n=230,244) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 4:Moderately (n=230,244) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 4:Moderately (n=230,244) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 4:Moderately (n=230,244) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 4:Moderately (n=230,244) | 18 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 4:Markedly (n=230,244) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 4:Markedly (n=230,244) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 4:Markedly (n=230,244) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 5:Normal (n=227,232) | 88 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 5:Normal (n=227,232) | 16 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 5:Normal (n=227,232) | 6 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 5:Normal (n=227,232) | 4 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 5:Borderline (n=227,232) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 5:Borderline (n=227,232) | 30 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 5:Borderline (n=227,232) | 4 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 5:Borderline (n=227,232) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 5:Mildly (n=227,232) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 5:Mildly (n=227,232) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 5:Mildly (n=227,232) | 39 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 5:Mildly (n=227,232) | 15 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 5:Mildly (n=227,232) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 5:Moderately (n=227,232) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 5:Moderately (n=227,232) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 5:Moderately (n=227,232) | 4 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 5:Moderately (n=227,232) | 15 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 5:Moderately (n=227,232) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 5:Markedly (n=227,232) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 6:Normal (n=224,225) | 84 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 6:Normal (n=224,225) | 18 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 6:Normal (n=224,225) | 4 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 6:Normal (n=224,225) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 6:Borderline (n=224,225) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 6:Borderline (n=224,225) | 24 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 6:Borderline (n=224,225) | 7 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 6:Borderline (n=224,225) | 4 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 6:Mildly (n=224,225) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 6:Mildly (n=224,225) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 6:Mildly (n=224,225) | 37 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 6:Mildly (n=224,225) | 15 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 6:Mildly (n=224,225) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 6:Moderately (n=224,225) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 6:Moderately (n=224,225) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 6:Moderately (n=224,225) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 6:Moderately (n=224,225) | 14 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 6:Markedly (n=224,225) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 6:Markedly (n=224,225) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 7:Normal (n=226,225) | 88 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 7:Normal (n=226,225) | 20 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 7:Normal (n=226,225) | 5 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 7:Normal (n=226,225) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 7:Borderline (n=226,225) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 7:Borderline (n=226,225) | 23 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 7:Borderline (n=226,225) | 6 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 7:Borderline (n=226,225) | 8 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 7:Borderline (n=226,225) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 7:Mildly (n=226,225) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 7:Mildly (n=226,225) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 7:Mildly (n=226,225) | 37 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 7:Mildly (n=226,225) | 10 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 7:Mildly (n=226,225) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 7:Moderately (n=226,225) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 7:Moderately (n=226,225) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 7:Moderately (n=226,225) | 4 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 7:Moderately (n=226,225) | 14 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 7:Moderately (n=226,225) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 7:Markedly (n=226,225) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 8:Normal (n=221,216) | 87 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 8:Normal (n=221,216) | 19 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 8:Normal (n=221,216) | 6 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 8:Normal (n=221,216) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 8:Borderline (n=221,216) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 8:Borderline (n=221,216) | 19 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 8:Borderline (n=221,216) | 7 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 8:Borderline (n=221,216) | 5 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 8:Borderline (n=221,216) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 8:Mildly (n=221,216) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 8:Mildly (n=221,216) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 8:Mildly (n=221,216) | 35 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 8:Mildly (n=221,216) | 13 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 8:Mildly (n=221,216) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 8:Moderately (n=221,216) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 8:Moderately (n=221,216) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 8:Moderately (n=221,216) | 12 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 8:Moderately (n=221,216) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 8:Markedly (n=221,216) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 8:Markedly (n=221,216) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 9:Normal (n=218,213) | 87 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 9:Normal (n=218,213) | 18 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 9:Normal (n=218,213) | 5 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 9:Normal (n=218,213) | 4 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 9:Borderline (n=218,213) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 9:Borderline (n=218,213) | 19 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 9:Borderline (n=218,213) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 9:Borderline (n=218,213) | 8 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 9:Borderline (n=218,213) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 9:Mildly (n=218,213) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 9:Mildly (n=218,213) | 4 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 9:Mildly (n=218,213) | 38 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 9:Mildly (n=218,213) | 9 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 9:Moderately (n=218,213) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 9:Moderately (n=218,213) | 12 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 9:Moderately (n=218,213) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 9:Markedly (n=218,213) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 9:Markedly (n=218,213) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 10:Normal (n=212,210) | 85 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 10:Normal (n=212,210) | 21 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 10:Normal (n=212,210) | 5 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 10:Normal (n=212,210) | 5 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 10:Borderline (n=212,210) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 10:Borderline (n=212,210 | 18 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 10:Borderline (n=212,210) | 6 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 10:Borderline(n=212,210) | 7 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 10:Borderline(n=212,210) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 10:Mildly (n=212,210) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 10:Mildly (n=212,210) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 10:Mildly (n=212,210) | 35 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 10:Mildly (n=212,210) | 11 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 10:Moderately (n=212,210) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 10:Moderately (n=212,210) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 10:Moderately(n=212,210) | 9 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 10:Moderately (n=212,210) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 10:Markedly (n=212,210) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 11:Normal (n=211,205) | 81 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 11:Normal (n=211,205) | 22 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 11:Normal (n=211,205) | 6 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 11:Normal (n=211,205) | 5 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 11:Normal (n=211,205) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 11:Borderline (n=211,205) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 11:Borderline(n=211,205) | 15 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 11:Borderline (n=211,205) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 11:Borderline(n=211,205) | 6 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 11:Borderline (n=211,205) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 11:Mildly (n=211,205) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 11:Mildly (n=211,205) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 11:Mildly (n=211,205) | 34 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 11:Mildly (n=211,205) | 13 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 11:Moderately (n=211,205) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 11:Moderately (n=211,205) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 11:Moderately(n=211,205) | 10 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 11:Moderately (n=211,205) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 11:Markedly (n=211,205) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 12:Normal (n=210,203) | 79 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 12:Normal (n=210,203) | 22 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 12:Normal (n=210,203) | 6 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 12:Normal (n=210,203) | 8 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 12:Normal (n=210,203) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 12:Borderline (n=210,203) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 12:Borderline(n=210,203) | 16 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 12:Borderline (n=210,203) | 4 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 12:Borderline(n=210,203) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 12:Borderline (n=210,203) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 12:Mildly (n=210,203) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 12:Mildly (n=210,203) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 12:Mildly (n=210,203) | 34 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 12:Mildly (n=210,203) | 14 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 12:Moderately(n=210,203) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 12:Moderately (n=210,203) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 12:Moderately(n=210,203) | 6 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 12:Moderately(n=210,203) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 12:Markedly(n=210,203) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 13:Normal (n=211,199) | 78 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 13:Normal (n=211,199) | 21 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 13:Normal (n=211,199) | 5 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 13:Normal (n=211,199) | 9 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 13:Normal (n=211,199) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 13:Borderline (n=211,199) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 13:Borderline(n=211,199) | 17 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 13:Borderline (n=211,199) | 6 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 13:Borderline(n=211,199) | 4 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 13:Borderline(n=211,199) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 13:Mildly (n=211,199) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 13:Mildly (n=211,199) | 32 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 13:Mildly (n=211,199) | 11 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 13:Moderately (n=211,199) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 13:Moderately(n=211,199) | 7 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 13:Moderately(n=211,199) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 13:Markedly (n=211,199) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 16:Normal (n=203,198) | 78 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 16:Normal (n=203,198) | 20 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 16:Normal (n=203,198) | 6 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 16:Normal (n=203,198) | 11 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 16:Normal (n=203,198) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 32:Normal (n=188,187) | 77 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 16:Borderline (n=203,198) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 16:Borderline(n=203,198) | 16 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 16:Borderline (n=203,198) | 5 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 16:Borderline(n=203,198) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 16:Borderline (n=203,198) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 16:Mildly (n=203,198) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 16:Mildly (n=203,198) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 16:Mildly (n=203,198) | 30 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 16:Mildly (n=203,198) | 8 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 16:Moderately(n=203,198) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 16:Moderately (n=203,198) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 16:Moderately(n=203,198) | 8 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 16:Moderately (n=203,198) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 16:Markedly (n=203,198) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 24:Normal (n=196,192) | 78 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 52:Normal (n=178,179) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 24:Normal (n=196,192) | 19 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 24:Normal (n=196,192) | 6 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 24:Normal (n=196,192) | 8 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 24:Borderline (n=196,192) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 24:Borderline(n=196,192) | 14 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 24:Borderline (n=196,192) | 6 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 24:Borderline(n=196,192) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 24:Borderline (n=196,192) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 24:Mildly (n=196,192) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 24:Mildly (n=196,192) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 24:Mildly (n=196,192) | 31 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 24:Mildly (n=196,192) | 12 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 24:Moderately (n=196,192) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 24:Moderately(n=196,192) | 7 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 24:Moderately (n=196,192) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 24:Markedly (n=196,192) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 32:Normal (n=188,187) | 20 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 32:Normal (n=188,187) | 8 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 32:Normal (n=188,187) | 9 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 32:Normal (n=188,187) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 32:Borderline (n=188,187) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 32:Borderline(n=188,187) | 15 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 32:Borderline (n=188,187) | 7 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 32:Borderline(n=188,187) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 32:Borderline (n=188,187) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 32:Mildly (n=188,187) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 32:Mildly (n=188,187) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 32:Mildly (n=188,187) | 29 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 32:Mildly (n=188,187) | 11 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 32:Mildly (n=188,187) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 32:Moderately (n=188,187) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 32:Moderately(n=188,187) | 5 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 32:Markedly (n=188,187) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 32:Markedly (n=188,187) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 40:Normal (n=180,181) | 71 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 40:Normal (n=180,181) | 20 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 40:Normal (n=180,181) | 7 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 40:Normal (n=180,181) | 7 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 40:Normal (n=180,181) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 40:Borderline (n=180,181) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 40:Borderline(n=180,181) | 15 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 40:Borderline (n=180,181) | 6 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 40:Borderline(n=180,181) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 40:Borderline (n=180,181) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 40:Mildly (n=180,181) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 40:Mildly (n=180,181) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 40:Mildly (n=180,181) | 28 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 40:Mildly (n=180,181) | 12 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 40:Mildly (n=180,181) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 40:Moderately (n=180,181) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 40:Moderately (n=180,181) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 40:Moderately(n=180,181) | 3 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 40:Markedly (n=180,181) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 52:Normal (n=178,179) | 69 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 52:Normal (n=178,179) | 20 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 52:Normal (n=178,179) | 7 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 52:Normal (n=178,179) | 7 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 52:Borderline (n=178,179) | 4 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 52:Borderline(n=178,179) | 14 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 52:Borderline (n=178,179) | 8 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 52:Borderline(n=178,179) | 4 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 52:Borderline (n=178,179) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Normal; Week 52:Mildly (n=178,179) | 0 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Borderline; Week 52:Mildly (n=178,179) | 2 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 52:Mildly (n=178,179) | 26 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 52:Mildly (n=178,179) | 11 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Mildly; Week 52:Moderately (n=178,179) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Moderately; Week 52:Moderately(n=178,179) | 4 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 52:Moderately (n=178,179) | 1 participants |
| Placebo | Number of Participants With Clinical Global Impression - Severity (CGI-S) Score | Baseline:Markedly; Week 24:Normal (n=196,192) | 0 participants |