Safety And Efficacy Of 12 Weeks Of Varenicline For Smokin... | NCT01078298

Label	Type	Description	Intervention Names
varenicline	Experimental		Drug: varenicline
placebo	Placebo Comparator	placebo	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
varenicline	Drug	varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks	varenicline

Measure	Description	Time Frame
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).	Week 9 through Week 12

Measure	Description	Time Frame
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.	Week 9 through Week 24, Week 9 through Week 52

Measure	Description	Time Frame
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.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Collaborative Neuroscience Network, Inc.		Garden Grove	California	92845	United States
California Neuroscience Research Medical Group, Inc

PubMed Identifier	Type	Citation	Retractions
37142273	Derived	Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
24042367	Derived	Anthenelli RM, Morris C, Ramey TS, Dubrava SJ, Tsilkos K, Russ C, Yunis C. Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial. Ann Intern Med. 2013 Sep 17;159(6):390-400. doi: 10.7326/0003-4819-159-6-201309170-00005.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	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.
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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).

All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.

Posted

Number

Percentage of participants

Week 9 through Week 12

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000256 OG001269

Title

Denominators

Categories

Title	Measurements
	OG00035.9 OG00115.6

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.	Regression, Logistic		<0.0001		Odds Ratio (OR)	3.35			2-Sided	95	2.16	5.21				No	Superiority or Other

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.

All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.

Posted

Number

Percentage of participants

Week 9 through Week 24, Week 9 through Week 52

ID	Title	Description
OG000	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.
OG001	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.

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.

All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.

Posted

Number

participants

Weeks 12, 24, 52

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

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.

All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.

Posted

Number

participants

Week 52

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

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.

Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement.

Posted

Number

participants

Baseline up to Week 16

ID	Title	Description
OG000	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.
OG001	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.

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

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.

Posted

Number

participants

Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52

ID	Title	Description
OG000	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.
OG001	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.

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

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.

Posted

Number

participants

Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

Units on a scale

Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Mean

Standard Deviation

Units on a scale

Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Mean

Standard Deviation

Units on a scale

Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16

ID	Title	Description
OG000	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.
OG001	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.

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").

Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement.

Posted

Number

participants

Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])

ID	Title	Description
OG000	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.
OG001	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.

Title

Denominators

Categories

Baseline:Normal; Week 1:Normal (n=250,263)

Title	Measurements
	OG000105 OG001100

Baseline:Borderline; Week 1:Normal (n=250,263)

Title	Measurements
	OG0007 OG0018

Baseline:Mildly; Week 1:Normal (n=250,263)

Title	Measurements
	OG0004 OG0011

Baseline:Moderately; Week 1:Normal (n=250,263)

Title	Measurements
	OG0001 OG0010

Baseline:Normal; Week 1:Borderline (n=250,263)

Title	Measurements
	OG0003 OG0013

Baseline:Borderline; Week 1:Borderline (n=250,263)

Title	Measurements
	OG00031 OG00142

Baseline:Mildly; Week 1:Borderline (n=250,263)

Title	Measurements
	OG0009 OG0013

Baseline:Moderately; Week 1:Borderline (n=250,263)

Title	Measurements
	OG0002 OG0013

Baseline:Normal; Week 1:Mildly (n=250,263)

Title	Measurements
	OG0000 OG0012

Baseline:Borderline; Week 1:Mildly (n=250,263)

Title	Measurements
	OG0004 OG0011

Baseline:Mildly; Week 1:Mildly (n=250,263)

Title	Measurements
	OG00046 OG00156

Baseline:Moderately; Week 1:Mildly (n=250,263)

Title	Measurements
	OG0006 OG0019

Baseline:Borderline; Week 1:Moderately (n=250,263)

Title	Measurements
	OG0001 OG0012

Baseline:Mildly; Week 1:Moderately (n=250,263)

Title	Measurements
	OG0001 OG0010

Baseline:Moderately; Week 1:Moderately (n=250,263)

Title	Measurements
	OG00028 OG00130

Baseline:Markedly; Week 1:Moderately (n=250,263)

Title	Measurements
	OG0001 OG0010

Baseline:Markedly; Week 1:Markedly (n=250,263)

Title	Measurements
	OG0001 OG0013

Baseline:Normal; Week 2:Normal (n=244,254)

Title	Measurements
	OG000102 OG00196

Baseline:Borderline; Week 2:Normal (n=244,254)

Title	Measurements
	OG00013 OG00112

Baseline:Mildly; Week 2:Normal (n=244,254)

Title	Measurements
	OG0005 OG0010

Baseline: Moderately; Week 2:Normal (n=244,254)

Title	Measurements
	OG0000 OG0011

Baseline:Normal; Week 2:Borderline (n=244,254)

Title	Measurements
	OG0001 OG0015

Baseline:Borderline; Week 2:Borderline (n=244,254)

Title	Measurements
	OG00022 OG00137

Baseline:Mildly; Week 2:Borderline (n=244,254)

Title	Measurements
	OG00010 OG0017

Baseline:Moderately; Week 2:Borderline (n=244,254)

Title	Measurements
	OG0004 OG0014

Baseline:Normal; Week 2:Mildly (n=244,254)

Title	Measurements
	OG0003 OG0012

Baseline:Borderline; Week 2:Mildly (n=244,254)

Title	Measurements
	OG0004 OG0010

Baseline:Mildly; Week 2:Mildly (n=244,254)

Title	Measurements
	OG00040 OG00148

Baseline:Moderately; Week 2:Mildly (n=244,254)

Title	Measurements
	OG00010 OG00112

Baseline:Markedly; Week 2:Mildly (n=244,254)

Title	Measurements
	OG0001 OG0010

Baseline:Normal; Week 2:Moderately (n=244,254)

Title	Measurements
	OG0002 OG0010

Baseline:Borderline; Week 2:Moderately (n=244,254)

Title	Measurements
	OG0001 OG0011

Baseline:Mildly; Week 2:Moderately (n=244,254)

Title	Measurements
	OG0002 OG0012

Baseline:Moderately; Week 2:Moderately (n=244,254)

Title	Measurements
	OG00020 OG00124

Baseline:Markedly; Week 2:Moderately (n=244,254)

Title	Measurements
	OG0000 OG0011

Baseline: Moderately; Week 2:Markedly (n=244,254)

Title	Measurements
	OG0003 OG0010

Baseline:Markedly; Week 2:Markedly (n=244,254)

Title	Measurements
	OG0001 OG0012

Baseline:Normal; Week 3:Normal (n=241,247)

Title	Measurements
	OG000101 OG00195

Baseline:Borderline; Week 3:Normal (n=241,247)

Title	Measurements
	OG00018 OG00116

Baseline:Mildly; Week 3:Normal (n=241,247)

Title	Measurements
	OG0006 OG0014

Baseline:Moderately; Week 3:Normal (n=241,247)

Title	Measurements
	OG0002 OG0010

Baseline:Normal; Week 3:Borderline (n=241,247)

Title	Measurements
	OG0003 OG0012

Baseline:Borderline; Week 3:Borderline (n=241,247)

Title	Measurements
	OG00016 OG00134

Baseline:Mildly; Week 3:Borderline (n=241,247)

Title	Measurements
	OG0008 OG0017

Baseline:Moderately; Week 3:Borderline (n=241,247)

Title	Measurements
	OG0004 OG0012

Baseline:Normal; Week 3:Mildly (n=241,247)

Title	Measurements
	OG0002 OG0010

Baseline:Borderline; Week 3:Mildly (n=241,247)

Title	Measurements
	OG0006 OG0012

Baseline:Mildly; Week 3:Mildly (n=241,247)

Title	Measurements
	OG00042 OG00142

Baseline:Moderately; Week 3:Mildly (n=241,247)

Title	Measurements
	OG00010 OG00117

Baseline:Markedly; Week 3:Mildly (n=241,247)

Title	Measurements
	OG0001 OG0010

Baseline:Normal; Week 3:Moderately (n=241,247)

Title	Measurements
	OG0000 OG0012

Baseline:Mildly; Week 3:Moderately (n=241,247)

Title	Measurements
	OG0002 OG0011

Baseline:Moderately; Week 3:Moderately (n=241,247)

Title	Measurements
	OG00019 OG00120

Baseline:Markedly; Week 3:Moderately (n=241,247)

Title	Measurements
	OG0000 OG0011

Baseline:Moderately; Week 3:Markedly (n=241,247)

Title	Measurements
	OG0000 OG0011

Baseline:Markedly; Week 3:Markedly (n=241,247)

Title	Measurements
	OG0001 OG0011

Baseline:Normal; Week 4:Normal (n=230,244)

Title	Measurements
	OG000101 OG00192

Baseline:Borderline; Week 4:Normal (n=230,244)

Title	Measurements
	OG00017 OG00117

Baseline:Mildly; Week 4:Normal (n=230,244)

Title	Measurements
	OG0007 OG0015

Baseline:Moderately; Week 4:Normal (n=230,244)

Title	Measurements
	OG0004 OG0011

Baseline:Normal; Week 4:Borderline (n=230,244)

Title	Measurements
	OG0002 OG0015

Baseline:Borderline; Week 4:Borderline (n=230,244)

Title	Measurements
	OG00017 OG00127

Baseline:Mildly; Week 4:Borderline (n=230,244)

Title	Measurements
	OG0008 OG0017

Baseline:Moderately; Week 4:Borderline (n=230,244)

Title	Measurements
	OG0001 OG0013

Baseline:Normal; Week 4:Mildly (n=230,244)

Title	Measurements
	OG0000 OG0012

Baseline:Borderline; Week 4:Mildly (n=230,244)

Title	Measurements
	OG0003 OG0012

Baseline:Mildly; Week 4:Mildly (n=230,244)

Title	Measurements
	OG00039 OG00143

Baseline:Moderately; Week 4:Mildly (n=230,244)

Title	Measurements
	OG00011 OG00115

Baseline:Markedly; Week 4:Mildly (n=230,244)

Title	Measurements
	OG0001 OG0011

Baseline:Borderline; Week 4:Moderately (n=230,244)

Title	Measurements
	OG0002 OG0010

Baseline:Mildly; Week 4:Moderately (n=230,244)

Title	Measurements
	OG0002 OG0012

Baseline:Moderately; Week 4:Moderately (n=230,244)

Title	Measurements
	OG00012 OG0012

Baseline:Markedly; Week 4:Moderately (n=230,244)

Title	Measurements
	OG0001 OG00118

Baseline:Borderline; Week 4:Markedly (n=230,244)

Title	Measurements
	OG0001 OG0010

Baseline:Moderately; Week 4:Markedly (n=230,244)

Title	Measurements
	OG0001 OG0010

Baseline:Markedly; Week 4:Markedly (n=230,244)

Title	Measurements
	OG0000 OG0012

Baseline:Normal; Week 5:Normal (n=227,232)

Title	Measurements
	OG00098 OG00188

Baseline:Borderline; Week 5:Normal (n=227,232)

Title	Measurements
	OG00019 OG00116

Baseline:Mildly; Week 5:Normal (n=227,232)

Title	Measurements
	OG0008 OG0016

Baseline:Moderately; Week 5:Normal (n=227,232)

Title	Measurements
	OG0004 OG0014

Baseline:Normal; Week 5:Borderline (n=227,232)

Title	Measurements
	OG0002 OG0011

Baseline:Borderline; Week 5:Borderline (n=227,232)

Title	Measurements
	OG00013 OG00130

Baseline:Mildly; Week 5:Borderline (n=227,232)

Title	Measurements
	OG0008 OG0014

Baseline:Moderately; Week 5:Borderline (n=227,232)

Title	Measurements
	OG0002 OG0013

Baseline:Normal; Week 5:Mildly (n=227,232)

Title	Measurements
	OG0002 OG0011

Baseline:Borderline; Week 5:Mildly (n=227,232)

Title	Measurements
	OG0006 OG0012

Baseline:Mildly; Week 5:Mildly (n=227,232)

Title	Measurements
	OG00036 OG00139

Baseline:Moderately; Week 5:Mildly (n=227,232)

Title	Measurements
	OG00011 OG00115

Baseline:Markedly; Week 5:Mildly (n=227,232)

Title	Measurements
	OG0002 OG0011

Baseline:Normal; Week 5:Moderately (n=227,232)

Title	Measurements
	OG0000 OG0011

Baseline:Borderline; Week 5:Moderately (n=227,232)

Title	Measurements
	OG0001 OG0010

Baseline:Mildly; Week 5:Moderately (n=227,232)

Title	Measurements
	OG0002 OG0014

Baseline:Moderately; Week 5:Moderately (n=227,232)

Title	Measurements
	OG00012 OG00115

Baseline:Markedly; Week 5:Moderately (n=227,232)

Title	Measurements
	OG0000 OG0011

Baseline:Moderately; Week 5:Markedly (n=227,232)

Title	Measurements
	OG0001 OG0011

Baseline:Normal; Week 6:Normal (n=224,225)

Title	Measurements
	OG00096 OG00184

Baseline:Borderline; Week 6:Normal (n=224,225)

Title	Measurements
	OG00022 OG00118

Baseline:Mildly; Week 6:Normal (n=224,225)

Title	Measurements
	OG00010 OG0014

Baseline:Moderately; Week 6:Normal (n=224,225)

Title	Measurements
	OG0003 OG0011

Baseline:Normal; Week 6:Borderline (n=224,225)

Title	Measurements
	OG0003 OG0013

Baseline:Borderline; Week 6:Borderline (n=224,225)

Title	Measurements
	OG00011 OG00124

Baseline:Mildly; Week 6:Borderline (n=224,225)

Title	Measurements
	OG0006 OG0017

Baseline:Moderately; Week 6:Borderline (n=224,225)

Title	Measurements
	OG0005 OG0014

Baseline:Normal; Week 6:Mildly (n=224,225)

Title	Measurements
	OG0002 OG0012

Baseline:Borderline; Week 6:Mildly (n=224,225)

Title	Measurements
	OG0005 OG0012

Baseline:Mildly; Week 6:Mildly (n=224,225)

Title	Measurements
	OG00038 OG00137

Baseline:Moderately; Week 6:Mildly (n=224,225)

Title	Measurements
	OG0008 OG00115

Baseline:Markedly; Week 6:Mildly (n=224,225)

Title	Measurements
	OG0002 OG0011

Baseline:Normal; Week 6:Moderately (n=224,225)

Title	Measurements
	OG0000 OG0013

Baseline:Borderline; Week 6:Moderately (n=224,225)

Title	Measurements
	OG0001 OG0011

Baseline:Mildly; Week 6:Moderately (n=224,225)

Title	Measurements
	OG0001 OG0013

Baseline:Moderately; Week 6:Moderately (n=224,225)

Title	Measurements
	OG00010 OG00114

Baseline:Moderately; Week 6:Markedly (n=224,225)

Title	Measurements
	OG0001 OG0011

Baseline:Markedly; Week 6:Markedly (n=224,225)

Title	Measurements
	OG0000 OG0011

Baseline:Normal; Week 7:Normal (n=226,225)

Title	Measurements
	OG00093 OG00188

Baseline:Borderline; Week 7:Normal (n=226,225)

Title	Measurements
	OG00023 OG00120

Baseline:Mildly; Week 7:Normal (n=226,225)

Title	Measurements
	OG00014 OG0015

Baseline:Moderately; Week 7:Normal (n=226,225)

Title	Measurements
	OG0003 OG0011

Baseline:Normal; Week 7:Borderline (n=226,225)

Title	Measurements
	OG0005 OG0012

Baseline:Borderline; Week 7:Borderline (n=226,225)

Title	Measurements
	OG00013 OG00123

Baseline:Mildly; Week 7:Borderline (n=226,225)

Title	Measurements
	OG0004 OG0016

Baseline:Moderately; Week 7:Borderline (n=226,225)

Title	Measurements
	OG0005 OG0018

Baseline:Markedly; Week 7:Borderline (n=226,225)

Title	Measurements
	OG0001 OG0010

Baseline:Normal; Week 7:Mildly (n=226,225)

Title	Measurements
	OG0002 OG0010

Baseline:Borderline; Week 7:Mildly (n=226,225)

Title	Measurements
	OG0002 OG0012

Baseline:Mildly; Week 7:Mildly (n=226,225)

Title	Measurements
	OG00036 OG00137

Baseline:Moderately; Week 7:Mildly (n=226,225)

Title	Measurements
	OG00010 OG00110

Baseline:Markedly; Week 7:Mildly (n=226,225)

Title	Measurements
	OG0001 OG0011

Baseline:Normal; Week 7:Moderately (n=226,225)

Title	Measurements
	OG0000 OG0011

Baseline:Borderline; Week 7:Moderately (n=226,225)

Title	Measurements
	OG0001 OG0011

Baseline:Mildly; Week 7:Moderately (n=226,225)

Title	Measurements
	OG0002 OG0014

Baseline:Moderately; Week 7:Moderately (n=226,225)

Title	Measurements
	OG00010 OG00114

Baseline:Markedly; Week 7:Moderately (n=226,225)

Title	Measurements
	OG0000 OG0011

Baseline:Moderately; Week 7:Markedly (n=226,225)

Title	Measurements
	OG0001 OG0011

Baseline:Normal; Week 8:Normal (n=221,216)

Title	Measurements
	OG00092 OG00187

Baseline:Borderline; Week 8:Normal (n=221,216)

Title	Measurements
	OG00021 OG00119

Baseline:Mildly; Week 8:Normal (n=221,216)

Title	Measurements
	OG00012 OG0016

Baseline:Moderately; Week 8:Normal (n=221,216)

Title	Measurements
	OG0003 OG0013

Baseline:Normal; Week 8:Borderline (n=221,216)

Title	Measurements
	OG0004 OG0012

Baseline:Borderline; Week 8:Borderline (n=221,216)

Title	Measurements
	OG00014 OG00119

Baseline:Mildly; Week 8:Borderline (n=221,216)

Title	Measurements
	OG0006 OG0017

Baseline:Moderately; Week 8:Borderline (n=221,216)

Title	Measurements
	OG0007 OG0015

Baseline:Markedly; Week 8:Borderline (n=221,216)

Title	Measurements
	OG0002 OG0010

Baseline:Normal; Week 8:Mildly (n=221,216)

Title	Measurements
	OG0002 OG0010

Baseline:Borderline; Week 8:Mildly (n=221,216)

Title	Measurements
	OG0003 OG0012

Baseline:Mildly; Week 8:Mildly (n=221,216)

Title	Measurements
	OG00032 OG00135

Baseline:Moderately; Week 8:Mildly (n=221,216)

Title	Measurements
	OG0009 OG00113

Baseline:Markedly; Week 8:Mildly (n=221,216)

Title	Measurements
	OG0000 OG0011

Baseline:Normal; Week 8:Moderately (n=221,216)

Title	Measurements
	OG0001 OG0010

Baseline:Mildly; Week 8:Moderately (n=221,216)

Title	Measurements
	OG0003 OG0013

Baseline:Moderately; Week 8:Moderately (n=221,216)

Title	Measurements
	OG0009 OG00112

Baseline:Markedly; Week 8:Moderately (n=221,216)

Title	Measurements
	OG0000 OG0011

Baseline:Mildly; Week 8:Markedly (n=221,216)

Title	Measurements
	OG0000 OG0011

Baseline:Moderately; Week 8:Markedly (n=221,216)

Title	Measurements
	OG0001 OG0010

Baseline:Normal; Week 9:Normal (n=218,213)

Title	Measurements
	OG00091 OG00187

Baseline:Borderline; Week 9:Normal (n=218,213)

Title	Measurements
	OG00022 OG00118

Baseline:Mildly; Week 9:Normal (n=218,213)

Title	Measurements
	OG00011 OG0015

Baseline:Moderately; Week 9:Normal (n=218,213)

Title	Measurements
	OG0004 OG0014

Baseline:Normal; Week 9:Borderline (n=218,213)

Title	Measurements
	OG0003 OG0012

Baseline:Borderline; Week 9:Borderline (n=218,213)

Title	Measurements
	OG00013 OG00119

Baseline:Mildly; Week 9:Borderline (n=218,213)

Title	Measurements
	OG0006 OG0013

Baseline:Moderately; Week 9:Borderline (n=218,213)

Title	Measurements
	OG0006 OG0018

Baseline:Markedly; Week 9:Borderline (n=218,213)

Title	Measurements
	OG0002 OG0011

Baseline:Normal; Week 9:Mildly (n=218,213)

Title	Measurements
	OG0003 OG0010

Baseline:Borderline; Week 9:Mildly (n=218,213)

Title	Measurements
	OG0002 OG0014

Baseline:Mildly; Week 9:Mildly (n=218,213)

Title	Measurements
	OG00034 OG00138

Baseline:Moderately; Week 9:Mildly (n=218,213)

Title	Measurements
	OG00010 OG0019

Baseline:Mildly; Week 9:Moderately (n=218,213)

Title	Measurements
	OG0001 OG0010

Baseline:Moderately; Week 9:Moderately (n=218,213)

Title	Measurements
	OG0008 OG00112

Baseline:Markedly; Week 9:Moderately (n=218,213)

Title	Measurements
	OG0000 OG0011

Baseline:Mildly; Week 9:Markedly (n=218,213)

Title	Measurements
	OG0001 OG0011

Baseline:Moderately; Week 9:Markedly (n=218,213)

Title	Measurements
	OG0001 OG0011

Baseline:Normal; Week 10:Normal (n=212,210)

Title	Measurements
	OG00088 OG00185

Baseline:Borderline; Week 10:Normal (n=212,210)

Title	Measurements
	OG00020 OG00121

Baseline:Mildly; Week 10:Normal (n=212,210)

Title	Measurements
	OG00013 OG0015

Baseline:Moderately; Week 10:Normal (n=212,210)

Title	Measurements
	OG0007 OG0015

Baseline:Normal; Week 10:Borderline (n=212,210)

Title	Measurements
	OG0005 OG0011

Baseline:Borderline; Week 10:Borderline (n=212,210

Title	Measurements
	OG00014 OG00118

Baseline:Mildly; Week 10:Borderline (n=212,210)

Title	Measurements
	OG0006 OG0016

Baseline:Moderately; Week 10:Borderline(n=212,210)

Title	Measurements
	OG0004 OG0017

Baseline:Markedly; Week 10:Borderline(n=212,210)

Title	Measurements
	OG0002 OG0011

Baseline:Normal; Week 10:Mildly (n=212,210)

Title	Measurements
	OG0001 OG0011

Baseline:Borderline; Week 10:Mildly (n=212,210)

Title	Measurements
	OG0001 OG0012

Baseline:Mildly; Week 10:Mildly (n=212,210)

Title	Measurements
	OG00029 OG00135

Baseline:Moderately; Week 10:Mildly (n=212,210)

Title	Measurements
	OG0008 OG00111

Baseline:Normal; Week 10:Moderately (n=212,210)

Title	Measurements
	OG0001 OG0010

Baseline:Mildly; Week 10:Moderately (n=212,210)

Title	Measurements
	OG0003 OG0011

Baseline:Moderately; Week 10:Moderately(n=212,210)

Title	Measurements
	OG0009 OG0019

Baseline:Markedly; Week 10:Moderately (n=212,210)

Title	Measurements
	OG0000 OG0011

Baseline:Moderately; Week 10:Markedly (n=212,210)

Title	Measurements
	OG0001 OG0011

Baseline:Normal; Week 11:Normal (n=211,205)

Title	Measurements
	OG00090 OG00181

Baseline:Borderline; Week 11:Normal (n=211,205)

Title	Measurements
	OG00023 OG00122

Baseline:Mildly; Week 11:Normal (n=211,205)

Title	Measurements
	OG00013 OG0016

Baseline:Moderately; Week 11:Normal (n=211,205)

Title	Measurements
	OG0007 OG0015

Baseline:Markedly; Week 11:Normal (n=211,205)

Title	Measurements
	OG0001 OG0010

Baseline:Normal; Week 11:Borderline (n=211,205)

Title	Measurements
	OG0003 OG0012

Baseline:Borderline; Week 11:Borderline(n=211,205)

Title	Measurements
	OG00010 OG00115

Baseline:Mildly; Week 11:Borderline (n=211,205)

Title	Measurements
	OG0006 OG0013

Baseline:Moderately; Week 11:Borderline(n=211,205)

Title	Measurements
	OG0003 OG0016

Baseline:Markedly; Week 11:Borderline (n=211,205)

Title	Measurements
	OG0001 OG0011

Baseline:Normal; Week 11:Mildly (n=211,205)

Title	Measurements
	OG0001 OG0010

Baseline:Borderline; Week 11:Mildly (n=211,205)

Title	Measurements
	OG0002 OG0013

Baseline:Mildly; Week 11:Mildly (n=211,205)

Title	Measurements
	OG00030 OG00134

Baseline:Moderately; Week 11:Mildly (n=211,205)

Title	Measurements
	OG0009 OG00113

Baseline:Normal; Week 11:Moderately (n=211,205)

Title	Measurements
	OG0000 OG0011

Baseline:Mildly; Week 11:Moderately (n=211,205)

Title	Measurements
	OG0003 OG0011

Baseline:Moderately; Week 11:Moderately(n=211,205)

Title	Measurements
	OG0008 OG00110

Baseline:Markedly; Week 11:Moderately (n=211,205)

Title	Measurements
	OG0000 OG0011

Baseline:Mildly; Week 11:Markedly (n=211,205)

Title	Measurements
	OG0000 OG0011

Baseline:Normal; Week 12:Normal (n=210,203)

Title	Measurements
	OG00089 OG00179

Baseline:Borderline; Week 12:Normal (n=210,203)

Title	Measurements
	OG00023 OG00122

Baseline:Mildly; Week 12:Normal (n=210,203)

Title	Measurements
	OG00013 OG0016

Baseline:Moderately; Week 12:Normal (n=210,203)

Title	Measurements
	OG0006 OG0018

Baseline:Markedly; Week 12:Normal (n=210,203)

Title	Measurements
	OG0001 OG0010

Baseline:Normal; Week 12:Borderline (n=210,203)

Title	Measurements
	OG0004 OG0012

Baseline:Borderline; Week 12:Borderline(n=210,203)

Title	Measurements
	OG00012 OG00116

Baseline:Mildly; Week 12:Borderline (n=210,203)

Title	Measurements
	OG0006 OG0014

Baseline:Moderately; Week 12:Borderline(n=210,203)

Title	Measurements
	OG0004 OG0013

Baseline:Markedly; Week 12:Borderline (n=210,203)

Title	Measurements
	OG0001 OG0011

Baseline:Normal; Week 12:Mildly (n=210,203)

Title	Measurements
	OG0000 OG0012

Baseline:Borderline; Week 12:Mildly (n=210,203)

Title	Measurements
	OG0000 OG0011

Baseline:Mildly; Week 12:Mildly (n=210,203)

Title	Measurements
	OG00030 OG00134

Baseline:Moderately; Week 12:Mildly (n=210,203)

Title	Measurements
	OG0009 OG00114

Baseline:Borderline; Week 12:Moderately(n=210,203)

Title	Measurements
	OG0000 OG0011

Baseline:Mildly; Week 12:Moderately (n=210,203)

Title	Measurements
	OG0003 OG0013

Baseline:Moderately; Week 12:Moderately(n=210,203)

Title	Measurements
	OG0008 OG0016

Baseline:Markedly; Week 12:Moderately(n=210,203)

Title	Measurements
	OG0000 OG0011

Baseline:Moderately; Week 12:Markedly(n=210,203)

Title	Measurements
	OG0001 OG0010

Baseline:Normal; Week 13:Normal (n=211,199)

Title	Measurements
	OG00092 OG00178

Baseline:Borderline; Week 13:Normal (n=211,199)

Title	Measurements
	OG00022 OG00121

Baseline:Mildly; Week 13:Normal (n=211,199)

Title	Measurements
	OG00013 OG0015

Baseline:Moderately; Week 13:Normal (n=211,199)

Title	Measurements
	OG0006 OG0019

Baseline:Markedly; Week 13:Normal (n=211,199)

Title	Measurements
	OG0002 OG0010

Baseline:Normal; Week 13:Borderline (n=211,199)

Title	Measurements
	OG0003 OG0013

Baseline:Borderline; Week 13:Borderline(n=211,199)

Title	Measurements
	OG00011 OG00117

Baseline:Mildly; Week 13:Borderline (n=211,199)

Title	Measurements
	OG0007 OG0016

Baseline:Moderately; Week 13:Borderline(n=211,199)

Title	Measurements
	OG0005 OG0014

Baseline:Markedly; Week 13:Borderline(n=211,199)

Title	Measurements
	OG0000 OG0011

Baseline:Borderline; Week 13:Mildly (n=211,199)

Title	Measurements
	OG0000 OG0013

Baseline:Mildly; Week 13:Mildly (n=211,199)

Title	Measurements
	OG00030 OG00132

Baseline:Moderately; Week 13:Mildly (n=211,199)

Title	Measurements
	OG0009 OG00111

Baseline:Mildly; Week 13:Moderately (n=211,199)

Title	Measurements
	OG0003 OG0011

Baseline:Moderately; Week 13:Moderately(n=211,199)

Title	Measurements
	OG0007 OG0017

Baseline:Markedly; Week 13:Moderately(n=211,199)

Title	Measurements
	OG0000 OG0011

Baseline:Moderately; Week 13:Markedly (n=211,199)

Title	Measurements
	OG0001 OG0010

Baseline:Normal; Week 16:Normal (n=203,198)

Title	Measurements
	OG00091 OG00178

Baseline:Borderline; Week 16:Normal (n=203,198)

Title	Measurements
	OG00019 OG00120

Baseline:Mildly; Week 16:Normal (n=203,198)

Title	Measurements
	OG00014 OG0016

Baseline:Moderately; Week 16:Normal (n=203,198)

Title	Measurements
	OG0007 OG00111

Baseline:Markedly; Week 16:Normal (n=203,198)

Title	Measurements
	OG0002 OG0010

Baseline:Normal; Week 16:Borderline (n=203,198)

Title	Measurements
	OG0002 OG0012

Baseline:Borderline; Week 16:Borderline(n=203,198)

Title	Measurements
	OG00011 OG00116

Baseline:Mildly; Week 16:Borderline (n=203,198)

Title	Measurements
	OG0004 OG0015

Baseline:Moderately; Week 16:Borderline(n=203,198)

Title	Measurements
	OG0002 OG0012

Baseline:Markedly; Week 16:Borderline (n=203,198)

Title	Measurements
	OG0000 OG0011

Baseline:Normal; Week 16:Mildly (n=203,198)

Title	Measurements
	OG0001 OG0012

Baseline:Borderline; Week 16:Mildly (n=203,198)

Title	Measurements
	OG0000 OG0013

Baseline:Mildly; Week 16:Mildly (n=203,198)

Title	Measurements
	OG00030 OG00130

Baseline:Moderately; Week 16:Mildly (n=203,198)

Title	Measurements
	OG00011 OG0018

Baseline:Borderline; Week 16:Moderately(n=203,198)

Title	Measurements
	OG0000 OG0012

Baseline:Mildly; Week 16:Moderately (n=203,198)

Title	Measurements
	OG0003 OG0012

Baseline:Moderately; Week 16:Moderately(n=203,198)

Title	Measurements
	OG0004 OG0018

Baseline:Markedly; Week 16:Moderately (n=203,198)

Title	Measurements
	OG0000 OG0011

Baseline:Moderately; Week 16:Markedly (n=203,198)

Title	Measurements
	OG0002 OG0011

Baseline:Normal; Week 24:Normal (n=196,192)

Title	Measurements
	OG00088 OG00178

Baseline:Borderline; Week 24:Normal (n=196,192)

Title	Measurements
	OG00018 OG00119

Baseline:Mildly; Week 24:Normal (n=196,192)

Title	Measurements
	OG00015 OG0016

Baseline:Moderately; Week 24:Normal (n=196,192)

Title	Measurements
	OG0005 OG0018

Baseline:Markedly; Week 24:Normal (n=196,192)

Title	Measurements
	OG0002 OG0010

Baseline:Normal; Week 24:Borderline (n=196,192)

Title	Measurements
	OG0000 OG0013

Baseline:Borderline; Week 24:Borderline(n=196,192)

Title	Measurements
	OG00013 OG00114

Baseline:Mildly; Week 24:Borderline (n=196,192)

Title	Measurements
	OG0004 OG0016

Baseline:Moderately; Week 24:Borderline(n=196,192)

Title	Measurements
	OG0002 OG0012

Baseline:Markedly; Week 24:Borderline (n=196,192)

Title	Measurements
	OG0000 OG0011

Baseline:Normal; Week 24:Mildly (n=196,192)

Title	Measurements
	OG0002 OG0011

Baseline:Borderline; Week 24:Mildly (n=196,192)

Title	Measurements
	OG0000 OG0013

Baseline:Mildly; Week 24:Mildly (n=196,192)

Title	Measurements
	OG00027 OG00131

Baseline:Moderately; Week 24:Mildly (n=196,192)

Title	Measurements
	OG0008 OG00112

Baseline:Mildly; Week 24:Moderately (n=196,192)

Title	Measurements
	OG0004 OG0010

Baseline:Moderately; Week 24:Moderately(n=196,192)

Title	Measurements
	OG0007 OG0017

Baseline:Markedly; Week 24:Moderately (n=196,192)

Title	Measurements
	OG0000 OG0011

Baseline:Moderately; Week 24:Markedly (n=196,192)

Title	Measurements
	OG0001 OG0010

Baseline:Normal; Week 32:Normal (n=188,187)

Title	Measurements
	OG00082 OG00177

Baseline:Borderline; Week 32:Normal (n=188,187)

Title	Measurements
	OG00016 OG00120

Baseline:Mildly; Week 32:Normal (n=188,187)

Title	Measurements
	OG00010 OG0018

Baseline:Moderately; Week 32:Normal (n=188,187)

Title	Measurements
	OG0004 OG0019

Baseline:Markedly; Week 32:Normal (n=188,187)

Title	Measurements
	OG0002 OG0010

Baseline:Normal; Week 32:Borderline (n=188,187)

Title	Measurements
	OG0000 OG0011

Baseline:Borderline; Week 32:Borderline(n=188,187)

Title	Measurements
	OG00012 OG00115

Baseline:Mildly; Week 32:Borderline (n=188,187)

Title	Measurements
	OG0009 OG0017

Baseline:Moderately; Week 32:Borderline(n=188,187)

Title	Measurements
	OG0004 OG0011

Baseline:Markedly; Week 32:Borderline (n=188,187)

Title	Measurements
	OG0000 OG0011

Baseline:Normal; Week 32:Mildly (n=188,187)

Title	Measurements
	OG0002 OG0010

Baseline:Borderline; Week 32:Mildly (n=188,187)

Title	Measurements
	OG0000 OG0011

Baseline:Mildly; Week 32:Mildly (n=188,187)

Title	Measurements
	OG00028 OG00129

Baseline:Moderately; Week 32:Mildly (n=188,187)

Title	Measurements
	OG0008 OG00111

Baseline:Markedly; Week 32:Mildly (n=188,187)

Title	Measurements
	OG0000 OG0011

Baseline:Mildly; Week 32:Moderately (n=188,187)

Title	Measurements
	OG0003 OG0010

Baseline:Moderately; Week 32:Moderately(n=188,187)

Title	Measurements
	OG0007 OG0015

Baseline:Borderline; Week 32:Markedly (n=188,187)

Title	Measurements
	OG0000 OG0011

Baseline:Moderately; Week 32:Markedly (n=188,187)

Title	Measurements
	OG0001 OG0010

Baseline:Normal; Week 40:Normal (n=180,181)

Title	Measurements
	OG00081 OG00171

Baseline:Borderline; Week 40:Normal (n=180,181)

Title	Measurements
	OG00017 OG00120

Baseline:Mildly; Week 40:Normal (n=180,181)

Title	Measurements
	OG00011 OG0017

Baseline:Moderately; Week 40:Normal (n=180,181)

Title	Measurements
	OG0002 OG0017

Baseline:Markedly; Week 40:Normal (n=180,181)

Title	Measurements
	OG0002 OG0010

Baseline:Normal; Week 40:Borderline (n=180,181)

Title	Measurements
	OG0000 OG0012

Baseline:Borderline; Week 40:Borderline(n=180,181)

Title	Measurements
	OG0009 OG00115

Baseline:Mildly; Week 40:Borderline (n=180,181)

Title	Measurements
	OG0008 OG0016

Baseline:Moderately; Week 40:Borderline(n=180,181)

Title	Measurements
	OG0004 OG0012

Baseline:Markedly; Week 40:Borderline (n=180,181)

Title	Measurements
	OG0000 OG0011

Baseline:Normal; Week 40:Mildly (n=180,181)

Title	Measurements
	OG0001 OG0010

Baseline:Borderline; Week 40:Mildly (n=180,181)

Title	Measurements
	OG0002 OG0012

Baseline:Mildly; Week 40:Mildly (n=180,181)

Title	Measurements
	OG00025 OG00128

Baseline:Moderately; Week 40:Mildly (n=180,181)

Title	Measurements
	OG00011 OG00112

Baseline:Markedly; Week 40:Mildly (n=180,181)

Title	Measurements
	OG0000 OG0011

Baseline:Normal; Week 40:Moderately (n=180,181)

Title	Measurements
	OG0000 OG0011

Baseline:Mildly; Week 40:Moderately (n=180,181)

Title	Measurements
	OG0002 OG0011

Baseline:Moderately; Week 40:Moderately(n=180,181)

Title	Measurements
	OG0004 OG0013

Baseline:Moderately; Week 40:Markedly (n=180,181)

Title	Measurements
	OG0001 OG0012

Baseline:Normal; Week 52:Normal (n=178,179)

Title	Measurements
	OG00081 OG00169

Baseline:Borderline; Week 52:Normal (n=178,179)

Title	Measurements
	OG00019 OG00120

Baseline:Mildly; Week 52:Normal (n=178,179)

Title	Measurements
	OG00012 OG0017

Baseline:Moderately; Week 52:Normal (n=178,179)

Title	Measurements
	OG0004 OG0017

Baseline:Markedly; Week 52:Normal (n=178,179)

Title	Measurements
	OG0002 OG0010

Baseline:Normal; Week 52:Borderline (n=178,179)

Title	Measurements
	OG0001 OG0014

Baseline:Borderline; Week 52:Borderline(n=178,179)

Title	Measurements
	OG0008 OG00114

Baseline:Mildly; Week 52:Borderline (n=178,179)

Title	Measurements
	OG0008 OG0018

Baseline:Moderately; Week 52:Borderline(n=178,179)

Title	Measurements
	OG0004 OG0014

Baseline:Markedly; Week 52:Borderline (n=178,179)

Title	Measurements
	OG0000 OG0011

Baseline:Normal; Week 52:Mildly (n=178,179)

Title	Measurements
	OG0001 OG0010

Baseline:Borderline; Week 52:Mildly (n=178,179)

Title	Measurements
	OG0000 OG0012

Baseline:Mildly; Week 52:Mildly (n=178,179)

Title	Measurements
	OG00024 OG00126

Baseline:Moderately; Week 52:Mildly (n=178,179)

Title	Measurements
	OG0008 OG00111

Baseline:Mildly; Week 52:Moderately (n=178,179)

Title	Measurements
	OG0001 OG0011

Baseline:Moderately; Week 52:Moderately(n=178,179)

Title	Measurements
	OG0004 OG0014

Baseline:Markedly; Week 52:Moderately (n=178,179)

Title	Measurements
	OG0000 OG0011

Baseline:Moderately; Week 52:Markedly (n=178,179)

Title	Measurements
	OG0001 OG0010

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected256 at risk EG0010 affected269 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected256 at risk EG0010 affected269 at risk
Chest pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected256 at risk EG0011 affected269 at risk
Device dislocation	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected256 at risk EG0011 affected269 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected256 at risk EG0010 affected269 at risk
Bronchitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected256 at risk EG0011 affected269 at risk
Device related infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected256 at risk EG0011 affected269 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 affected256 at risk EG0011 affected269 at risk
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 affected256 at risk EG0011 affected269 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected256 at risk EG0010 affected269 at risk
Ligament laxity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected256 at risk EG0010 affected269 at risk
Agitation	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected256 at risk EG0011 affected269 at risk
Depression	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected256 at risk EG0011 affected269 at risk
Depression suicidal	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected256 at risk EG0011 affected269 at risk
Intentional sefl-injury	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected256 at risk EG0011 affected269 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected256 at risk EG0010 affected269 at risk
Claculus ureteric	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected256 at risk EG0010 affected269 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected256 at risk EG0011 affected269 at risk
Haemodynamic instability	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected256 at risk EG0010 affected269 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00015 affected256 at risk EG0019 affected269 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00016 affected256 at risk EG00112 affected269 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00017 affected256 at risk EG00114 affected269 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00069 affected256 at risk EG00128 affected269 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00013 affected256 at risk EG0019 affected269 at risk
Irritability	General disorders	MedDRA 15.0	Non-systematic Assessment	EG00028 affected256 at risk EG00122 affected269 at risk
Nasopharyngitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG00014 affected256 at risk EG00113 affected269 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG00015 affected256 at risk EG00113 affected269 at risk
Weight increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG00014 affected256 at risk EG0015 affected269 at risk
Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00043 affected256 at risk EG00130 affected269 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG00029 affected256 at risk EG00122 affected269 at risk
Agitation	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG00017 affected256 at risk EG00110 affected269 at risk
Anxiety	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG00018 affected256 at risk EG00125 affected269 at risk
Depression	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG00017 affected256 at risk EG00113 affected269 at risk
Insomnia	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG00028 affected256 at risk EG00113 affected269 at risk

ID	Term
D016540	Smoking Cessation
D003863	Depression
D012907	Smoking

ID	Term
D015438	Health Behavior
D001519	Behavior
D001526	Behavioral Symptoms

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D011810	Quinoxalines

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			7	256	158	256
EG001	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.			7	269	126	269