Trial Outcomes & Findings for Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome (NCT NCT02311673)

Last Updated: 2023-07-27

Results Overview

An adverse event (AE) was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE is considered to be treatment-emergent if the onset date/time is during or after administration of double-blind study drug or, in the event that onset time precedes double-blind study drug administration, the AE increases in severity during or after administration of double-blind study drug; in either case through 1-week after the last treatment dose. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent disability/incapacity; * Was a congenital anomaly/birth defect

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Days 15 to 41

Results posted on

2023-07-27

Participant Flow

Of the 44 participants screened, 40 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	Setmelanotide 0.5 mg Participants received placebo matched to setmelanotide once daily as a subcutaneous injection from Day 1 to Day 14 (2-week, single-blind placebo run-in period); thereafter, participants received setmelanotide 0.5 milligrams (mg) once daily as a subcutaneous injection from Day 15 to Day 41 (4-week, double-blind randomized treatment period) and Day 42 to Day 55 (2-week, randomized withdrawal period).	Setmelanotide 1.5 mg Participants received placebo matched to setmelanotide once daily as a subcutaneous injection from Day 1 to Day 14 (2-week, single-blind placebo run-in period); thereafter, participants received setmelanotide 1.5 once daily as a subcutaneous injection from Day 15 to Day 41 (4-week, double-blind randomized treatment period), Day 42 to Day 55 (2-week, randomized withdrawal period), and Day 56 to Day 69 (optional 2-week, open-label extension period).	Setmelanotide 2.5 mg Participants received placebo matched to setmelanotide once daily as a subcutaneous injection from Day 1 to Day 14 (2-week, single-blind placebo run-in period); thereafter, participants received setmelanotide 2.5 once daily as a subcutaneous injection from Day 15 to Day 41 (4-week, double-blind randomized treatment period), Day 42 to Day 55 (2-week, randomized withdrawal period), and Day 56 to Day 69 (optional 2-week, open-label extension period).	Placebo Participants received placebo matched to setmelanotide once daily as a subcutaneous injection from Day 1 to Day 14 (2-week, single-blind placebo run-in period), Day 15 to Day 41 (4-week, double-blind randomized treatment period), and Day 42 to Day 55 (2-week, randomized withdrawal period).
Placebo Run-in Period 1 (2 Weeks) STARTED	0	0	0	40
Placebo Run-in Period 1 (2 Weeks) COMPLETED	0	0	0	40
Placebo Run-in Period 1 (2 Weeks) NOT COMPLETED	0	0	0	0
Double-blind Randomized Period 2 (4 Wks) STARTED	4	13	8	15
Double-blind Randomized Period 2 (4 Wks) COMPLETED	4	13	7	15
Double-blind Randomized Period 2 (4 Wks) NOT COMPLETED	0	0	1	0
Randomized Withdrawal Period 3 (2 Weeks) STARTED	3	10	5	20
Randomized Withdrawal Period 3 (2 Weeks) COMPLETED	3	10	5	20
Randomized Withdrawal Period 3 (2 Weeks) NOT COMPLETED	0	0	0	0
Open-label Extension Period 4 (2 Weeks) STARTED	0	22	16	1
Open-label Extension Period 4 (2 Weeks) COMPLETED	0	22	16	1
Open-label Extension Period 4 (2 Weeks) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Setmelanotide 0.5 mg Participants received placebo matched to setmelanotide once daily as a subcutaneous injection from Day 1 to Day 14 (2-week, single-blind placebo run-in period); thereafter, participants received setmelanotide 0.5 milligrams (mg) once daily as a subcutaneous injection from Day 15 to Day 41 (4-week, double-blind randomized treatment period) and Day 42 to Day 55 (2-week, randomized withdrawal period).	Setmelanotide 1.5 mg Participants received placebo matched to setmelanotide once daily as a subcutaneous injection from Day 1 to Day 14 (2-week, single-blind placebo run-in period); thereafter, participants received setmelanotide 1.5 once daily as a subcutaneous injection from Day 15 to Day 41 (4-week, double-blind randomized treatment period), Day 42 to Day 55 (2-week, randomized withdrawal period), and Day 56 to Day 69 (optional 2-week, open-label extension period).	Setmelanotide 2.5 mg Participants received placebo matched to setmelanotide once daily as a subcutaneous injection from Day 1 to Day 14 (2-week, single-blind placebo run-in period); thereafter, participants received setmelanotide 2.5 once daily as a subcutaneous injection from Day 15 to Day 41 (4-week, double-blind randomized treatment period), Day 42 to Day 55 (2-week, randomized withdrawal period), and Day 56 to Day 69 (optional 2-week, open-label extension period).	Placebo Participants received placebo matched to setmelanotide once daily as a subcutaneous injection from Day 1 to Day 14 (2-week, single-blind placebo run-in period), Day 15 to Day 41 (4-week, double-blind randomized treatment period), and Day 42 to Day 55 (2-week, randomized withdrawal period).
Double-blind Randomized Period 2 (4 Wks) Withdrawal by participant and Investigator decision	0	0	1	0

Baseline Characteristics

Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Setmelanotide 0.5 mg n=4 Participants Participants received placebo matched to setmelanotide once daily as a subcutaneous injection from Day 1 to Day 14 (2-week, single-blind placebo run-in period); thereafter, participants received setmelanotide 0.5 milligrams (mg) once daily as a subcutaneous injection from Day 15 to Day 41 (4-week, double-blind randomized treatment period) and Day 42 to Day 55 (2-week, randomized withdrawal period).	Setmelanotide 1.5 mg n=13 Participants Participants received placebo matched to setmelanotide once daily as a subcutaneous injection from Day 1 to Day 14 (2-week, single-blind placebo run-in period); thereafter, participants received setmelanotide 1.5 once daily as a subcutaneous injection from Day 15 to Day 41 (4-week, double-blind randomized treatment period), Day 42 to Day 55 (2-week, randomized withdrawal period), and Day 56 to Day 69 (optional 2-week, open-label extension period).	Setmelanotide 2.5 mg n=8 Participants Participants received placebo matched to setmelanotide once daily as a subcutaneous injection from Day 1 to Day 14 (2-week, single-blind placebo run-in period); thereafter, participants received setmelanotide 2.5 once daily as a subcutaneous injection from Day 15 to Day 41 (4-week, double-blind randomized treatment period), Day 42 to Day 55 (2-week, randomized withdrawal period), and Day 56 to Day 69 (optional 2-week, open-label extension period).	Placebo n=15 Participants Participants received placebo matched to setmelanotide once daily as a subcutaneous injection from Day 1 to Day 14 (2-week, single-blind placebo run-in period), Day 15 to Day 41 (4-week, double-blind randomized treatment period), and Day 42 to Day 55 (2-week, randomized withdrawal period).	Total n=40 Participants Total of all reporting groups
Age, Continuous	21.3 years STANDARD_DEVIATION 4.19 • n=5 Participants	24.1 years STANDARD_DEVIATION 5.42 • n=7 Participants	25.0 years STANDARD_DEVIATION 9.62 • n=5 Participants	30.5 years STANDARD_DEVIATION 11.97 • n=4 Participants	26.4 years STANDARD_DEVIATION 9.47 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	21 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants	19 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	13 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants	36 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	15 Participants n=4 Participants	36 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Days 15 to 41

Population: Safety Set. Participants were classified into groups based on actual treatment received.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=13 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=8 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=15 Participants Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=4 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) - Period 2 Participants with at least 1 TEAE	11 Participants	6 Participants	11 Participants	4 Participants
Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) - Period 2 Participants with at least 1 SAE	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Days 42 to 55

Population: Participants in the Safety Set with available data were analyzed. Participants were classified into groups based on actual treatment received.

An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE is considered to be treatment-emergent if the onset date/time is during or after administration of double-blind study drug or, in the event that onset time precedes double-blind study drug administration, the AE increases in severity during or after administration of double-blind study drug; in either case through 1-week after the last treatment dose. An SAE was any untoward medical occurrence that, at any dose: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent disability/incapacity; * Was a congenital anomaly/birth defect

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=10 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=5 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=20 Participants Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=3 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Number of Participants Who Experienced a TEAE - Period 3 Participants with at least 1 TEAE	7 Participants	4 Participants	11 Participants	3 Participants
Number of Participants Who Experienced a TEAE - Period 3 Participants with at least 1 SAE	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Days 56 to 69

Population: Participants in the Safety Set with available data were analyzed. Participants were classified into groups based on actual treatment received.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=16 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=1 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=22 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Number of Participants Who Experienced a TEAE - Period 4 Participants with at least 1 TEAE	12 Participants	0 Participants	—	17 Participants
Number of Participants Who Experienced a TEAE - Period 4 Participants with at least 1 SAE	0 Participants	0 Participants	—	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 15)

Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of randomized study medication with a baseline and at least 1 postbaseline efficacy observation within Period 2. Participants were classified based on randomized treatment group, regardless of the actual treatment received. Participants in the FAS with available data were analyzed.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=12 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=9 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=13 Participants Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=4 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Mean Body Weight - Period 2	92.7 Kilograms (kg) Standard Error 5.50	101.6 Kilograms (kg) Standard Error 5.35	102.2 Kilograms (kg) Standard Error 9.16	94.3 Kilograms (kg) Standard Error 16.84

PRIMARY outcome

Timeframe: Baseline (Day 15) and Day 42

Population: Participants in the FAS with available data were analyzed. Participants were classified based on randomized treatment group, regardless of the actual treatment received.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=12 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=9 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=13 Participants Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=4 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Percent Change From Baseline in Body Weight - Period 2	-0.8 percent change Interval -2.2 to 0.6	0.4 percent change Interval -1.2 to 2.0	-0.4 percent change Interval -1.8 to 0.9	-0.7 percent change Interval -3.1 to 1.8

PRIMARY outcome

Timeframe: Baseline (Day 15)

Population: Participants in the FAS with available data were analyzed. Participants were classified based on randomized treatment group, regardless of the actual treatment received.

The hyperphagia questionnaire is a 10-item instrument designed to measure food-related preoccupations and problems in PWS, as well as the severity of these concerns. Three factors identified from this questionnaire are: Hyperphagic Drive, Hyperphagic Behaviors, and Hyperphagic Severity. Items are rated by care providers on a 5-point scale (1=not a problem to 5=a severe and/or frequent problem). Raw scores for each factor were used in data analyses, and the 3 domains were summed for an overall summary index of hyperphagia. Possible scores on the questionnaire range from a minimum score of 10 (no hyperphagia) to a maximum score of 50 (greater hyperphagia).

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=12 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=9 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=13 Participants Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=4 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Overall Score of Prader-Willi Syndrome (PWS) Hyperphagia Questionnaire - Period 2	21.2 units on a scale Standard Error 2.28	20.2 units on a scale Standard Error 2.79	18.7 units on a scale Standard Error 2.33	31.0 units on a scale Standard Error 2.86

PRIMARY outcome

Timeframe: Baseline (Day 15) and Day 42

Population: Participants in the FAS with available data were analyzed. Participants were classified based on randomized treatment group, regardless of the actual treatment received.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=12 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=9 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=13 Participants Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=4 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Percent Change From Baseline in Overall Score of Prader-Willi Syndrome (PWS) Hyperphagia Questionnaire - Period 2	-5.2 percent change Interval -21.3 to 10.9	-5.0 percent change Interval -23.7 to 13.6	-1.3 percent change Interval -16.9 to 14.3	20.2 percent change Interval -8.7 to 49.1

SECONDARY outcome

Timeframe: Baseline (Day 15) and Day 42

Population: Participants in the FAS with available data were analyzed. Participants were classified based on randomized treatment group, regardless of the actual treatment received.

The hyperphagia questionnaire is a 10-item instrument designed to measure food-related preoccupations and problems in PWS, as well as the severity of these concerns. Hyperphagic drive score assesses the persistence in asking for food based on 4 items. All 4 items are rated by care providers on a 5-point scale (1=not a problem to 5=a severe and/or frequent problem). Possible scores for hyperphagic drive range from a minimum score of 4 (no hyperphagic drive) to a maximum score of 20 (greater hyperphagic drive). Percent change from baseline in hyperphagic drive score of PWS hyperphagia questionnaire is presented.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=12 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=9 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=13 Participants Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=4 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Percent Change From Baseline in Hyperphagic Drive Score of PWS Hyperphagia Questionnaire - Period 2	-3.6 percent change Interval -24.1 to 16.9	-6.8 percent change Interval -30.5 to 16.8	6.6 percent change Interval -13.2 to 26.4	27.2 percent change Interval -8.9 to 63.3

SECONDARY outcome

Timeframe: Baseline (Day 15) and Day 42

Population: Participants in the FAS with available data were analyzed. Participants were classified based on randomized treatment group, regardless of the actual treatment received.

The hyperphagia questionnaire is a 10-item instrument designed to measure food-related preoccupations and problems in PWS, as well as the severity of these concerns. Hyperphagic behavior factor score assesses food seeking behaviors based on 4 items. All 4 items are rated by care providers on a 5-point scale (1=not a problem to 5=a severe and/or frequent problem). Possible scores for hyperphagic behaviors range from a minimum score of 4 (no hyperphagic behavior) to a maximum score of 20 (greater hyperphagic behavior). Percent change from baseline in hyperphagic behaviors score of PWS hyperphagia questionnaire is presented.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=12 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=9 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=13 Participants Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=4 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Percent Change From Baseline in Hyperphagic Behaviors Score of PWS Hyperphagia Questionnaire - Period 2	-1.7 percent change Interval -22.3 to 18.9	-3.0 percent change Interval -26.8 to 20.8	-0.4 percent change Interval -20.4 to 19.6	19.1 percent change Interval -19.3 to 57.5

SECONDARY outcome

Timeframe: Baseline (Day 15) and Day 42

Population: Participants in the FAS with available data were analyzed. Participants were classified based on randomized treatment group, regardless of the actual treatment received.

The hyperphagia questionnaire is a 10-item instrument designed to measure food-related preoccupations and problems in PWS, as well as the severity of these concerns. Hyperphagic severity factor score assesses the severity of hyperphagia based on 2 items. Both items are rated by care providers on a 5-point scale (1=not a problem to 5=a severe and/or frequent problem). Possible scores for hyperphagic severity range from a minimum score of 2 (no hyperphagic severity) to a maximum score of 10 (greater hyperphagic severity). Percent change from baseline in hyperphagic severity score of PWS hyperphagia questionnaire is presented.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=12 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=9 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=13 Participants Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=4 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Percent Change From Baseline in Hyperphagic Severity Score of PWS Hyperphagia Questionnaire - Period 2	-0.7 percent change Interval -22.1 to 20.6	5.5 percent change Interval -19.1 to 30.2	-16.7 percent change Interval -37.3 to 3.9	33.2 percent change Interval -4.4 to 70.9

SECONDARY outcome

Timeframe: Baseline (Day 42) and Day 56

Population: Participants in the FAS with available data were analyzed. Participants were classified based on randomized treatment group, regardless of the actual treatment received.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=10 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=5 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=20 Participants Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=3 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Percent Change From Baseline in Overall Score of PWS Hyperphagia Questionnaire - Period 3	-1.8 percent change Interval -18.4 to 14.7	3.4 percent change Interval -20.1 to 26.9	2.3 percent change Interval -9.6 to 14.2	35.0 percent change Interval -2.9 to 72.9

SECONDARY outcome

Timeframe: Baseline (Day 56) and Day 70

Population: Participants in the FAS with available data were analyzed. In Period 4, one participant was randomized to setmelanotide 2.5 mg treatment group but treated with placebo. As participants in the FAS are classified based on randomized treatment group regardless of the actual treatment received, the placebo group is not included in the FAS analysis for Period 4.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=20 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=15 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Percent Change From Baseline in Overall Score of PWS Hyperphagia Questionnaire - Period 4	-0.4 percent change Standard Deviation 29.94	—	—	-0.9 percent change Standard Deviation 23.21

SECONDARY outcome

Timeframe: 5 minutes predose on Day 42 and Day 70

Population: The Pharmacokinetic (PK) Evaluable Population was defined as all participants in the Safety Population who had evaluable plasma concentration-time profiles for setmelanotide in the substudy. One participant may have received more than one doses in different periods (eg, 0.5 mg in the Double-blind Randomized Treatment Period and 1.5 mg in the Randomized Withdrawal Period) and therefore included in multiple groups in the data presented.

The average of setmelanotide trough concentrations values for both timepoints (5 minutes predose on Day 42 and Day 70) is presented.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=27 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=29 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=4 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Mean Setmelanotide Trough Concentrations	2.59 nanograms per milliliter (ng/mL) Standard Deviation 1.51	5.63 nanograms per milliliter (ng/mL) Standard Deviation 4.19	—	0.790 nanograms per milliliter (ng/mL) Standard Deviation 0.336

SECONDARY outcome

Timeframe: Starting on any day from Day 63 through 69, a 24-hour PK profile obtained; blood samples were collected at 0 (within 5 minutes predose), 1, 2, 4, 6, 7, 8, 9, 10, 12, and 24 hours after dosing

Population: Participants in the PK Evaluable Population with available data were analyzed. Because only 1 participant was analyzed in the setmelanotide 1.5 mg group, no data are reported for this group in order to protect and maintain participant privacy/confidentiality.

Maximum drug concentration determined directly from individual concentration-time data.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=7 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Maximum Drug Concentration (Cmax) of Setmelanotide During a 24-Hour Steady-State Interval	—	—	—	39.1 ng/mL Standard Deviation 12.2

SECONDARY outcome

Maximum drug concentration determined directly from individual concentration-time data.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=7 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Time to the Maximum Drug Concentration (Tmax) of Setmelanotide During a 24-Hour Steady-State Interval	—	—	—	6.00 hours (hr) Interval 5.95 to 10.15

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=5 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Area Under the Drug Concentration-Time Curve From Time-Zero to 24 Hours Postdose (AUC24h) of Setmelanotide During a 24-Hour Steady-State Interval	—	—	—	569.4 hr*ng/mL Standard Deviation 190.6

SECONDARY outcome

Volume of distribution calculated as Dose/The observed terminal rate constant\*AUC24h.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=5 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Volume of Distribution (Vd) of Setmelanotide During a 24-Hour Steady-State Interval	—	—	—	52.8 Liters (L) Standard Deviation 10.0

SECONDARY outcome

Clearance after extravascular administration; calculated as Dose/AUC24h.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=5 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Total Clearance (CL) of Setmelanotide During a 24-Hour Steady-State Interval	—	—	—	4.77 L/hr Standard Deviation 1.49

SECONDARY outcome

Timeframe: Baseline (Day 15) and Day 42

Population: Participants in the FAS with available data were analyzed. Participants were classified based on randomized treatment group, regardless of the actual treatment received.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=12 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=9 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=13 Participants Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=4 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Change From Baseline in Body Weight - Period 2	-0.8 kg Interval -2.2 to 0.7	0.3 kg Interval -1.4 to 1.9	-0.4 kg Interval -1.8 to 1.0	-0.6 kg Interval -3.1 to 1.8

SECONDARY outcome

Timeframe: Baseline (Day 42) and Day 56

Population: Participants in the FAS with available data were analyzed. Participants were classified based on randomized treatment group, regardless of the actual treatment received.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=10 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=5 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=20 Participants Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=3 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Percent Change From Baseline in Body Weight - Period 3	0.0 percent change Interval -0.9 to 0.9	0.0 percent change Interval -1.3 to 1.3	0.2 percent change Interval -0.4 to 0.9	1.3 percent change Interval -0.3 to 2.9

SECONDARY outcome

Timeframe: Baseline (Day 56) and Day 70

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=20 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=19 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Percent Change From Baseline in Body Weight - Period 4	0.0 percent change Standard Deviation 2.70	—	—	-0.0 percent change Standard Deviation 0.90

SECONDARY outcome

Timeframe: Baseline (Day 15), Day 42, Day 56

Population: FAS population with available data were analyzed for participants who continued with the same treatment when switched from Double-blind Randomized Treatment to Randomized Withdrawal Period.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=6 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=4 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=7 Participants Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=2 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Percent Change From Baseline in Body Weight for Continuous Active and Continuous Placebo Treatments - Period 2 and 3 Percent change at Day 42	-0.5 percent change Interval -3.1 to 2.2	0.7 percent change Interval -2.6 to 4.0	-0.7 percent change Interval -3.2 to 1.7	-0.7 percent change Interval -5.3 to 3.9
Percent Change From Baseline in Body Weight for Continuous Active and Continuous Placebo Treatments - Period 2 and 3 Percent change at Day 56	-0.4 percent change Interval -3.3 to 2.6	0.9 percent change Interval -2.7 to 4.4	-1.0 percent change Interval -3.8 to 1.7	0.2 percent change Interval -4.8 to 5.3

SECONDARY outcome

Timeframe: Baseline (Day 15) and Day 42

Population: Participants in the FAS with available data were analyzed. Participants were classified based on randomized treatment group, regardless of the actual treatment received.

Total body fat was assessed by DEXA scan.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=12 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=8 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=13 Participants Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=4 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Percent Change From Baseline in Body Fat Measured Using Dual x-Ray Absorptiometry (DEXA) - Period 2	-1.1 percent change Interval -2.7 to 0.5	-0.7 percent change Interval -2.6 to 1.3	-1.1 percent change Interval -2.7 to 0.4	-0.6 percent change Interval -3.4 to 2.1

SECONDARY outcome

Timeframe: Baseline (Day 56) and Day 70

Total body fat was assessed by DEXA scan. Number of participants with clinically significant percent change from baseline in body fat were judged by investigator.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=20 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=19 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Number of Participants With Clinically Significant Percent Change From Baseline in Body Fat Measured Using DEXA - Period 4	0 Participants	—	—	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 15) and Day 42

Population: Participants in the FAS with available data were analyzed. Participants were classified based on randomized treatment group, regardless of the actual treatment received.

Total body mass was assessed by DEXA scan.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=12 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=8 Participants Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=13 Participants Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=4 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Percent Change From Baseline in Body Mass Measured Using DEXA - Period 2	-1.1 percent change Interval -2.3 to 0.2	-0.3 percent change Interval -1.8 to 1.2	-0.9 percent change Interval -2.1 to 0.3	-0.2 percent change Interval -2.3 to 1.9

SECONDARY outcome

Timeframe: Baseline (Day 56) and Day 70

Total body mass was assessed by DEXA scan. Number of participants with clinically significant percent change from baseline in body mass were judged by investigator.

Outcome measures

Outcome measures
Measure	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=20 Participants Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=19 Participants Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.
Number of Participants With Clinically Significant Percent Change From Baseline in Body Mass Measured Using DEXA - Period 4	0 Participants	—	—	0 Participants

Adverse Events

Setmelanotide 0.5 mg (Double-blind Randomized Treatment)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Setmelanotide 1.5 mg (Double-blind Randomized Treatment)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Setmelanotide 2.5 mg (Double-blind Randomized Treatment)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo (Double-blind Randomized Treatment)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Setmelanotide 0.5 mg (Randomized Withdrawal Period)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Setmelanotide 1.5 mg (Randomized Withdrawal Period)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Setmelanotide 2.5 mg (Randomized Withdrawal Period)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo (Randomized Withdrawal Period)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Setmelanotide 1.5 mg (Open-Label Extension)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Setmelanotide 2.5 mg (Open-Label Extension)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo (Open-Label Extension)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Setmelanotide 0.5 mg (Double-blind Randomized Treatment) n=4 participants at risk Participants received setmelanotide 0.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 1.5 mg (Double-blind Randomized Treatment) n=13 participants at risk Participants received setmelanotide 1.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 2.5 mg (Double-blind Randomized Treatment) n=8 participants at risk Participants received setmelanotide 2.5 mg once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Placebo (Double-blind Randomized Treatment) n=15 participants at risk Participants received placebo matched to setmelanotide once daily from Day 15 to Day 41 as a subcutaneous injection in a 4-week, double-blind randomized treatment period.	Setmelanotide 0.5 mg (Randomized Withdrawal Period) n=3 participants at risk Participants received setmelanotide 0.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.	Setmelanotide 1.5 mg (Randomized Withdrawal Period) n=10 participants at risk Participants received setmelanotide 1.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.	Setmelanotide 2.5 mg (Randomized Withdrawal Period) n=5 participants at risk Participants received setmelanotide 2.5 mg once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.	Placebo (Randomized Withdrawal Period) n=20 participants at risk Participants received placebo matched to setmelanotide once daily from Day 42 to Day 55 as a subcutaneous injection in a 2-week, randomized withdrawal period.	Setmelanotide 1.5 mg (Open-Label Extension) n=22 participants at risk Participants received setmelanotide 1.5 mg once daily from Day 56 to Day 69 as a subcutaneous injection in an optional 2-week, open-label extension period.	Setmelanotide 2.5 mg (Open-Label Extension) n=16 participants at risk Participants received setmelanotide 2.5 mg once daily from Day 56 to Day 69 as a subcutaneous injection in an optional 2-week, open-label extension period.	Placebo (Open-Label Extension) n=1 participants at risk The participant, due to an error in the IVRS, received placebo matched to setmelanotide once daily from Day 56 to Day 69 as a subcutaneous injection in an optional 2-week, open-label extension period.
General disorders Injection site bruising	75.0% 3/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	7.7% 1/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	12.5% 1/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	20.0% 3/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	33.3% 1/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	22.7% 5/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
General disorders Injection site erythema	75.0% 3/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	38.5% 5/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	50.0% 4/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	40.0% 6/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	66.7% 2/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	40.0% 4/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	80.0% 4/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	20.0% 4/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	36.4% 8/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	37.5% 6/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
General disorders Injection site induration	50.0% 2/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	30.8% 4/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	25.0% 2/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	20.0% 3/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	66.7% 2/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	20.0% 2/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	20.0% 4/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	27.3% 6/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	37.5% 6/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
General disorders Injection site oedema	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	15.4% 2/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	12.5% 1/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	13.3% 2/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	33.3% 1/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	20.0% 2/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	27.3% 6/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	12.5% 2/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
General disorders Injection site pain	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	7.7% 1/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	12.5% 1/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.7% 1/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	9.1% 2/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
General disorders Injection site pruritus	25.0% 1/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	23.1% 3/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.7% 1/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	33.3% 1/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	10.0% 1/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	9.1% 2/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.2% 1/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
General disorders Influenza like illness	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	7.7% 1/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
General disorders Injection site discolouration	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	7.7% 1/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	12.5% 2/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
General disorders Injection site nodule	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	7.7% 1/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
General disorders Injection site reaction	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	7.7% 1/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
General disorders Injection site swelling	25.0% 1/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
General disorders Non-cardiac chest pain	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Infections and infestations Skin infection	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.7% 1/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
General disorders Chest discomfort	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.2% 1/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
General disorders Injection site erosion	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	9.1% 2/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	12.5% 1/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	10.0% 1/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	12.5% 2/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Skin and subcutaneous tissue disorders Skin discolouration	25.0% 1/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	15.4% 2/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Skin and subcutaneous tissue disorders Ephelides	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	7.7% 1/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	10.0% 1/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	7.7% 1/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.7% 1/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.2% 1/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Skin and subcutaneous tissue disorders Skin erosion	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.7% 1/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.2% 1/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Skin and subcutaneous tissue disorders Solar lentigo	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Reproductive system and breast disorders Erection increased	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	12.5% 1/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Reproductive system and breast disorders Spontaneous penile erection	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	7.7% 1/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	10.0% 1/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Reproductive system and breast disorders Menorrhagia	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Reproductive system and breast disorders Genital disorder female	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Investigations Blood creatine phosphokinase increased	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	12.5% 1/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Musculoskeletal and connective tissue disorders Soft tissue mass	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	12.5% 1/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.2% 1/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Psychiatric disorders Aggression	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	7.7% 1/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Psychiatric disorders Sleep disorder	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	7.7% 1/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Psychiatric disorders Tearfulness	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	7.7% 1/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Psychiatric disorders Abnormal behaviour	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Psychiatric disorders Irritability	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Psychiatric disorders Mood altered	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Psychiatric disorders Insomnia	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Psychiatric disorders Libido increased	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Gastrointestinal disorders Flatulence	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	7.7% 1/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Gastrointestinal disorders Pigmentation lip	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	7.7% 1/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.7% 1/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.2% 1/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Gastrointestinal disorders Nausea	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.7% 1/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Nervous system disorders Headache	50.0% 2/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	7.7% 1/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	9.1% 2/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.2% 1/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Nervous system disorders Dizziness	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Infections and infestations Cellulitis	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.7% 1/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Infections and infestations Fungal infection	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.7% 1/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Infections and infestations Nasopharyngitis	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.7% 1/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	10.0% 1/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Infections and infestations Ear infection	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Infections and infestations Localised infection	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Infections and infestations Onychomycosis	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Infections and infestations Tinea pedis	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Infections and infestations Vaginal infection	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Injury, poisoning and procedural complications Scar	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.7% 1/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.2% 1/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Injury, poisoning and procedural complications Heat exhaustion	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.2% 1/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of skin	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.7% 1/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	5.0% 1/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.2% 1/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.7% 1/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	10.0% 2/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	12.5% 2/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Vascular disorders Hypertension	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.7% 1/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.
Cardiac disorders Palpitations	0.00% 0/4 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/13 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/8 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/15 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/3 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/10 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/5 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/20 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	4.5% 1/22 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	6.2% 1/16 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.	0.00% 0/1 • Day 15 to Day 69 Safety Set; participants were classified into groups based on actual treatment received. The single-blind placebo run-in period (Day 1 to Day 14) is not part of statistical analysis of this study; therefore, no AE data were collected for this period.

Additional Information

Rhythm Clinical Trials

Rhythm Pharmaceuticals, Inc.

Phone: 857-264-4280

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All information regarding setmelanotide supplied by Rhythm to the investigator is privileged and confidential information. The investigator agrees to use this information to accomplish the study and will not use it for other purposes without consent from Rhythm. The information obtained from the clinical study will be used towards the development of setmelanotide and may be disclosed to regulatory authority(ies), other investigators, corporate partners, or consultants as required.
Publication restrictions are in place

Restriction type: OTHER