Smoking Cessation Study In Healthy Adolescent Smokers | NCT01312909

ID	Type	Description	Link
CHANTIX	Other Identifier	Alias Study Number

Label	Type	Description	Intervention Names
Varenicline 1mg BID	Experimental	Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52	Drug: Varenicline 1mg BID
Varenicline 0.5mg BID	Experimental	Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52	Drug: Varenicline 0.5mg BID
Placebo	Placebo Comparator	Oral placebo for twelve weeks,follow-up through Week 52	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Varenicline 1mg BID	Drug	Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52

Measure	Description	Time Frame
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12	The percentage of participants who, at each visit from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and at each of these visits were confirmed to have quit based on urine cotinine less than 200 nanograms/milliliter (ng/mL).	Week 9 through Week 12

Measure	Description	Time Frame
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52	The percentage of participants who reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) on the Nicotine Use Inventory in the 7 days prior to the study visits or telephone contacts at Week 12,24 and 52.	Weeks 12, 24 and 52

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious AEs and SAEs.

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

Facility	Status	City	State	ZIP	Country	Contacts
IICR, Inc. (DBA: International Institute of Clinical Research)		Ozark	Alabama	36360	United States

PubMed Identifier	Type	Citation	Retractions
34062053	Derived	Fediuk DJ, Sweeney K, Sahasrabudhe V, McRae T, Byon W. Population pharmacokinetics and exposure-response analyses of varenicline in adolescent smokers. CPT Pharmacometrics Syst Pharmacol. 2021 Jul;10(7):769-781. doi: 10.1002/psp4.12645. Epub 2021 Jun 17.
32979939	Derived	Gray KM, Rubinstein ML, Prochaska JJ, DuBrava SJ, Holstein AR, Samuels L, McRae TD. High-dose and low-dose varenicline for smoking cessation in adolescents: a randomised, placebo-controlled trial. Lancet Child Adolesc Health. 2020 Nov;4(11):837-845. doi: 10.1016/S2352-4642(20)30243-1. Epub 2020 Sep 25.

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

ID	Title	Description
FG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 9, 2012	May 29, 2018

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

4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12

The percentage of participants who, at each visit from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and at each of these visits were confirmed to have quit based on urine cotinine less than 200 nanograms/milliliter (ng/mL).

The full analysis set included all randomized participants.

Posted

Number

percentage of participants

Week 9 through Week 12

ID	Title	Description
OG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
OG001	Varenicline Low Dose	Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.
OG002	Placebo	Participants received 2 tablets of placebo (matched to Varenicline) orally, twice daily from Week 2 to Week 12 after a 2-week titration.

Units	Counts
Participants	OG000109 OG001103 OG002100

Title

Denominators

Categories

Title	Measurements
	OG00020.2 OG00127.2 OG00218.0

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 OG002	Odds ratios and p-values were obtained from a logistic regression model with terms treatment, age strata, body weight strata and pooled center. A testing order was used to control type I error. 1mg Varenicline twice daily group was tested against placebo first, and if statistically significant difference was observed, the 0.5 mg Varenicline twice daily group was tested against placebo.	Regression, Logistic		0.6337	Threshold for significance at 0.05 level.	Odds Ratio (OR)	1.18			2-Sided	95	0.59	2.37					Superiority

Secondary

Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52

The percentage of participants who reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) on the Nicotine Use Inventory in the 7 days prior to the study visits or telephone contacts at Week 12,24 and 52.

The full analysis set included all randomized participants.

Posted

Number

percentage of participants

Weeks 12, 24 and 52

ID	Title	Description
OG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
OG001	Varenicline Low Dose	Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.

Secondary

Daily Number of Cigarettes Smoked at Baseline

The average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.

The full analysis set included all randomized participants.

Posted

Mean

Standard Error

cigarettes smoked per day

Baseline

ID	Title	Description
OG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
OG001	Varenicline Low Dose	Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.
OG002	Placebo

Secondary

Change From Baseline in Daily Number of Cigarettes Smoked at Weeks 12, 24, and 52

The reduction in the number of the cigarettes smoked was calculated by subtracting the reported average number of cigarettes smoked per day in the past 7 days at Weeks 12, 24 and 52 from the average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.

The full analysis set included all randomized participants. The longitudinal model included all participants regardless of observed visits.

Posted

Least Squares Mean

Standard Error

cigarettes smoked per day

Baseline, Weeks 12, 24, and 52

ID	Title	Description
OG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
OG001	Varenicline Low Dose	Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.

Secondary

Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and Week 52

The percentage of participants who, at each visit from Week 9 to 52 (inclusive), reported no smoking and no use of other nicotine-containing products (Weeks 9-12) or tobacco products (Weeks 13-52) since the last study visit/last contact (on the Nicotine Use Inventory) and at any of the study visits were confirmed to have quit based on urine cotinine less than 200 ng/mL.

The full analysis set included all randomized participants.

Posted

Number

percentage of participants

Week 9 through Week 24; Week 9 through Week 52

ID	Title	Description
OG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
OG001	Varenicline Low Dose	Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.

Other Pre-specified

Number of Participants With Treatment-Emergent Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious AEs and SAEs.

The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses.

Posted

Count of Participants

Participants

First dose up to last dose (up-to Week 12) plus 30 days

ID	Title	Description
OG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
OG001	Varenicline Low Dose

Other Pre-specified

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to drug Varenicline was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious AEs and SAEs.

The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses.

Posted

Count of Participants

Participants

First dose up to last dose (up-to Week 12) plus 30 days

ID	Title	Description
OG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.

Other Pre-specified

Number of Participants With Treatment-Emergent Neuropsychiatric Adverse Event Elicited by Neuropsychiatric Adverse Event Interview (NAEI)

An AE was any untoward medical occurrence attributed to study drug in a 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. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Solicited AEs collected by semi-structured NAEI inquiring about AEs: depression, anxiety, delusions, hallucinations, paranoia, psychosis, mania, panic, agitation, dissociative states, feeling abnormal, hostility, aggression and homicidal ideation. If a participant had a positive response to any item on the NAEI, investigator determined if it met criteria AE criteria.

The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses.

Posted

Count of Participants

Participants

First dose up to last dose (up-to Week 12) plus 30 days

ID	Title	Description
OG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.

Other Pre-specified

Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories);was an interview-based instrument to systematically assess suicidal ideation and suicidal behavior.C-SSRS assessed whether participant experienced any of the following:completed suicide;suicide attempt(response of "Yes" on "actual attempt");preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior","aborted attempt" or "interrupted attempt"),suicidal ideation ("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 specific plan or with specific plan and intent,any self-injurious behavior with no suicidal intent ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").Here,number of participants with positive response (response of "yes") to suicidal behavior or/and Ideation,any non-suicidal self-injurious behavior were reported.

The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses.

Posted

Count of Participants

Participants

Screening, Baseline, Week 1 up to Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (last follow-up [FU])

ID	Title	Description
OG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.

Other Pre-specified

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety (HADS-A) Total Scores at Specified Time-points

The HADS is a self-administered questionnaire measuring anxiety. Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A) consisted of 7 items that were assessed on a scale of 0 = no anxiety to 3 = severe feeling of anxiety. Total HADS-A subscale score range from 0 = no anxiety to 21 = severe anxiety; higher scores indicated more severe anxiety.

The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52

ID	Title	Description
OG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
OG001	Varenicline Low Dose	Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.

Other Pre-specified

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores - Depression Total Score at Specified Time-Points

Hospital Anxiety and Depression Scale Depression subscale (HADS-D) consists of 7 items that were assessed on a scale of 0 = no depression to 3 = severe feeling of depression. Total HADS-D subscale score range from 0 = no depression to 21 = severe feeling of depression; higher scores indicated a greater intensity of depression.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52

ID	Title	Description
OG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
OG001	Varenicline Low Dose	Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.

Other Pre-specified

Number of Participants With Laboratory Abnormalities

Criteria for laboratory abnormalities: Lymphocytes Absolute (Abs), Lymphocytes percentage (%), Total Neutrophils (Abs), Neutrophils %: <0.8*LLN or >1.2*ULN; Basophils (Abs), Basophils %Eosinophils (Abs), Eosinophils %, Monocytes (Abs), Monocytes %:> 1.2*ULN; Total Bilirubin milligram per deciliter (mg/dl) >1.5*ULN; alanine aminotransferase: >3.0*ULN; Blood urea nitrogen, Creatinine: >1.3*ULN; Uric acid :> 1.2*ULN.

The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses. Here, 'Number of Participants Analyzed= participants evaluable for this outcome measure.

Posted

Count of Participants

Participants

Baseline up to Week 12

ID	Title	Description
OG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
OG001	Varenicline Low Dose	Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.

Other Pre-specified

Change From Baseline in Blood Pressure (BP) at Week 12

Measurement of BP included supine and sitting systolic BP, standing systolic BP, supine and sitting diastolic BP and standing diastolic BP. Blood pressure was taken after participants rested in a sitting position for 5 minutes. BP was recorded after participants had been supine for approximately 5 minutes, and then orthostatic blood pressure was recorded immediately when the participant stood.

The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure.

Posted

Median

Full Range

millimeters of mercury (mmHg)

Baseline, Week 12

ID	Title	Description
OG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
OG001	Varenicline Low Dose	Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.

Other Pre-specified

Change From Baseline in Pulse Rate at Week 12

Measurement of pulse rate included supine, sitting and standing pulse rate. Pulse rate was taken after participants rested in a sitting position for 5 minutes. Pulse rate was recorded after participants had been supine for approximately 5 minutes and then immediately upon standing.

Posted

Median

Full Range

beats per minute (bpm)

Baseline, Week 12

ID	Title	Description
OG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
OG001	Varenicline Low Dose	Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukopenia	Blood and lymphatic system disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Visual impairment	Eye disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0003 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0013 affected100 at risk EG0021 affected99 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0002 affected108 at risk EG0011 affected100 at risk EG0022 affected99 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0002 affected108 at risk EG0011 affected100 at risk EG0023 affected99 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0011 affected100 at risk EG0021 affected99 at risk
Haematemesis	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Nausea	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG00026 affected108 at risk EG00119 affected100 at risk EG00212 affected99 at risk
Odynophagia	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0012 affected100 at risk EG0020 affected99 at risk
Toothache	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0012 affected100 at risk EG0021 affected99 at risk
Vomiting	Gastrointestinal disorders	MedDRA v20.1	Non-systematic Assessment	EG00014 affected108 at risk EG0012 affected100 at risk EG0022 affected99 at risk
Asthenia	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0012 affected100 at risk EG0020 affected99 at risk
Chest pain	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Chills	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Drug withdrawal syndrome	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Energy increased	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Fatigue	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Feeling jittery	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Malaise	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Pain	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0021 affected99 at risk
Pyrexia	General disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0012 affected100 at risk EG0021 affected99 at risk
Multiple allergies	Immune system disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Bronchitis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Conjunctivitis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Folliculitis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Furuncle	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Gastroenteritis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected100 at risk EG0022 affected99 at risk
Gastroenteritis viral	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Gonorrhoea	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Influenza	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0012 affected100 at risk EG0020 affected99 at risk
Laryngitis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Nasopharyngitis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0004 affected108 at risk EG0013 affected100 at risk EG0025 affected99 at risk
Pharyngitis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0013 affected100 at risk EG0020 affected99 at risk
Respiratory tract infection	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0022 affected99 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0003 affected108 at risk EG0010 affected100 at risk EG0023 affected99 at risk
Rhinitis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0021 affected99 at risk
Sinusitis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Tonsillitis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Tooth abscess	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0006 affected108 at risk EG0015 affected100 at risk EG0022 affected99 at risk
Urinary tract infection	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Viral infection	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0021 affected99 at risk
Viral pharyngitis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA v20.1	Non-systematic Assessment	EG0002 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA v20.1	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0013 affected100 at risk EG0021 affected99 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0021 affected99 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA v20.1	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Alanine aminotransferase increased	Investigations	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Blood pressure increased	Investigations	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Blood pressure orthostatic decreased	Investigations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0021 affected99 at risk
Body mass index increased	Investigations	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Neutrophil count decreased	Investigations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Weight increased	Investigations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0022 affected99 at risk
White blood cell count decreased	Investigations	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA v20.1	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0012 affected100 at risk EG0021 affected99 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Amnesia	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Disturbance in attention	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Dizziness	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0006 affected108 at risk EG0017 affected100 at risk EG0023 affected99 at risk
Dysgeusia	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0013 affected100 at risk EG0022 affected99 at risk
Headache	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG00014 affected108 at risk EG0015 affected100 at risk EG0028 affected99 at risk
Hypoaesthesia	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Lethargy	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Memory impairment	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Migraine	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Sinus headache	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Sleep paralysis	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Somnolence	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Tension headache	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0022 affected99 at risk
Tremor	Nervous system disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0021 affected99 at risk
Abnormal dreams	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0008 affected108 at risk EG0015 affected100 at risk EG0024 affected99 at risk
Adjustment disorder	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Agitation	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0009 affected108 at risk EG0015 affected100 at risk EG0025 affected99 at risk
Anxiety	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0006 affected108 at risk EG0014 affected100 at risk EG0027 affected99 at risk
Attention deficit/hyperactivity disorder	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Aversion	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Depressed mood	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0012 affected100 at risk EG0020 affected99 at risk
Depression	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0003 affected108 at risk EG0012 affected100 at risk EG0023 affected99 at risk
Dissociation	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Flat affect	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Grief reaction	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Hallucination	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0022 affected99 at risk
Hostility	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0007 affected108 at risk EG0013 affected100 at risk EG0024 affected99 at risk
Insomnia	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Irritability	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0002 affected108 at risk EG0013 affected100 at risk EG0021 affected99 at risk
Mania	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Middle insomnia	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Nightmare	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Restlessness	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Pollakiuria	Renal and urinary disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Urinary hesitation	Renal and urinary disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0022 affected99 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0002 affected108 at risk EG0012 affected100 at risk EG0020 affected99 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0011 affected100 at risk EG0021 affected99 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0013 affected100 at risk EG0020 affected99 at risk
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0011 affected100 at risk EG0021 affected99 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0022 affected99 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Hypotension	Vascular disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Initial insomnia	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk

ID	Term
D015438	Health Behavior
D001519	Behavior

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

ID	Title	Description
BG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.
BG001	Varenicline Low Dose	Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.
BG002	Placebo	Participants received 2 tablets of placebo (matched to Varenicline) orally, twice daily from Week 2 to Week 12 after a 2-week titration.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Varenicline High Dose	Participants received 2 tablets of Varenicline 0.5 milligram (mg) (total dose 1 mg) orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight less than or equal to (<=) 55 kilograms (kg) had Varenicline dose reduced by half, and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration.	108	3	108	65	108
EG001	Varenicline Low Dose	Participants received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, twice daily from Week 2 to Week 12 after a 2-week titration. Participants with a body weight <= 55 kg had Varenicline dose reduced by half and received one tablet of Varenicline 0.5 mg and one matching placebo tablet orally, in the morning and 2 tablets of matching placebo orally, in the evening from Week 2 to Week 12 after a 2-week titration.	100	1	100	53	100
EG002	Placebo	Participants received 2 tablets of placebo (matched to Varenicline) orally, twice daily from Week 2 to Week 12 after a 2-week titration.	99	1	99	51	99

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bile duct stone	Hepatobiliary disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected100 at risk EG0020 affected99 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Laryngitis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk
Salpingitis	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected100 at risk EG0021 affected99 at risk
Adjustment disorder with mixed disturbance of emotion and conduct	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected100 at risk EG0020 affected99 at risk