Trial Outcomes & Findings for A Study in Pediatric Participants With Generalized Anxiety Disorder (NCT NCT01226511)

Last Updated: 2014-03-05

Results Overview

PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\*visit, age category\*visit, and baseline\*visit.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

281 participants

Primary outcome timeframe

Baseline, 10 weeks

Results posted on

2014-03-05

Participant Flow

This study had 4 periods: Screening period (1-week), acute treatment period (10-week, double-blind period with flexible duloxetine dosing), extension treatment (18-week period, of which 16 weeks were open-label treatment with flexible duloxetine dosing), and a taper period (2 weeks recommended at discontinuation from study any point after Week 2).

Participant milestones

Participant milestones
Measure	Duloxetine/Duloxetine Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules. Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.	Placebo/Duloxetine Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules. Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.
Acute Treatment Period STARTED	140	141
Acute Treatment Period COMPLETED	108	110
Acute Treatment Period NOT COMPLETED	32	31
Extension Treatment Period STARTED	108	110
Extension Treatment Period COMPLETED	81	83
Extension Treatment Period NOT COMPLETED	27	27
Taper Period STARTED	51	57
Taper Period COMPLETED	46	54
Taper Period NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Duloxetine/Duloxetine Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules. Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.	Placebo/Duloxetine Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules. Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.
Acute Treatment Period Adverse Event	7	6
Acute Treatment Period Lack of Efficacy	2	1
Acute Treatment Period Lost to Follow-up	3	6
Acute Treatment Period Parent/caregiver decision	5	7
Acute Treatment Period Protocol Violation	5	5
Acute Treatment Period Withdrawal by Subject	10	6
Extension Treatment Period Adverse Event	8	8
Extension Treatment Period Lack of Efficacy	3	2
Extension Treatment Period Lost to Follow-up	4	3
Extension Treatment Period Protocol Violation	2	2
Extension Treatment Period Withdrawal by Subject	1	3
Extension Treatment Period Parent/Caregiver Decision	8	8
Extension Treatment Period Sponsor Decision	1	1
Taper Period Adverse Event	1	0
Taper Period Lost to Follow-up	2	2
Taper Period Protocol Violation	1	0
Taper Period Parent/Caregiver Decision	1	1

Baseline Characteristics

A Study in Pediatric Participants With Generalized Anxiety Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duloxetine/Duloxetine n=135 Participants Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules. Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.	Placebo/Duloxetine n=137 Participants Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules. Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.	Total n=272 Participants Total of all reporting groups
Age, Customized 7 to 11 years	62 participants n=5 Participants	66 participants n=7 Participants	128 participants n=5 Participants
Age, Customized 12 to 17 years	73 participants n=5 Participants	71 participants n=7 Participants	144 participants n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	75 Participants n=7 Participants	145 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	62 Participants n=7 Participants	127 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	37 Participants n=5 Participants	40 Participants n=7 Participants	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=5 Participants	88 Participants n=7 Participants	176 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	9 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants
Race/Ethnicity, Customized White	112 participants n=5 Participants	111 participants n=7 Participants	223 participants n=5 Participants
Race/Ethnicity, Customized More than 1 race	6 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment United States	98 participants n=5 Participants	99 participants n=7 Participants	197 participants n=5 Participants
Region of Enrollment Mexico	26 participants n=5 Participants	26 participants n=7 Participants	52 participants n=5 Participants
Region of Enrollment South Africa	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 10 weeks

Population: Randomized participants with a baseline and at least 1 post-baseline PARS severity score for GAD during the acute treatment period, excluding 9 participants from 1 site with major quality issues.

Outcome measures

Outcome measures
Measure	Duloxetine (Acute Treatment) n=135 Participants Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.	Placebo (Acute Treatment) n=133 Participants Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Change From Baseline to 10-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist	-9.70 units on a scale Standard Error 0.502	-7.05 units on a scale Standard Error 0.500

SECONDARY outcome

Timeframe: Baseline, 10 weeks

Population: Randomized participants with a baseline and at least 1 post-baseline PARS severity score for GAD \[last observation carried forward (LOCF)\] during the acute treatment period, excluding 9 participants from 1 site with major quality issues.

Response rate was defined as the percentage of participants having a 50% improvement from baseline to endpoint on the PARS severity score for GAD. PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity.

Outcome measures

Outcome measures
Measure	Duloxetine (Acute Treatment) n=135 Participants Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.	Placebo (Acute Treatment) n=133 Participants Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Response Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Pediatric Anxiety Rating Scale (PARS) Severity Score for GAD	51 percentage of participants 4.8	37 percentage of participants 4.8

SECONDARY outcome

Timeframe: Baseline, 10 weeks

Population: Randomized participants with a baseline and at least 1 post-baseline PARS severity total score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.

PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment\*visit, baseline\*visit, and age category\*visit.

Outcome measures

Outcome measures
Measure	Duloxetine (Acute Treatment) n=135 Participants Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.	Placebo (Acute Treatment) n=133 Participants Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Change From Baseline to 10-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms	-9.15 units on a scale Standard Error 0.479	-6.36 units on a scale Standard Error 0.477

SECONDARY outcome

Timeframe: Baseline, 10 weeks

Population: Randomized participants with a baseline and at least 1 post-baseline CGI-S score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.

The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment\*visit, baseline\*visit, and age category\*visit.

Outcome measures

Outcome measures
Measure	Duloxetine (Acute Treatment) n=135 Participants Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.	Placebo (Acute Treatment) n=133 Participants Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Change From Baseline to 10-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale	-1.93 units on a scale Standard Error 0.114	-1.38 units on a scale Standard Error 0.113

SECONDARY outcome

Timeframe: 10 weeks

Population: Randomized participants with at least 1 post-baseline CGI-S score \[last observation carried forward (LOCF)\] during the acute treatment period, excluding 9 participants from 1 site with major quality issues.

Remission rate was defined as the percentage of participants having a CGI-S score ≤2 at endpoint. The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness.

Outcome measures

Outcome measures
Measure	Duloxetine (Acute Treatment) n=135 Participants Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.	Placebo (Acute Treatment) n=133 Participants Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Remission Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Clinical Global Impressions of Severity (CGI-S) Scale	45 percentage of participants	30 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 10 weeks

Population: Randomized participants with a baseline and at least 1 post-baseline \[last observation carried forward (LOCF)\] CGAS score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.

The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for treatment, pooled investigator, baseline, and age category.

Outcome measures

Outcome measures
Measure	Duloxetine (Acute Treatment) n=123 Participants Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.	Placebo (Acute Treatment) n=124 Participants Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Change From Baseline to 10-Week Endpoint in the Children's Global Assessment Scale (CGAS)	17.14 units on a scale Standard Error 1.232	12.16 units on a scale Standard Error 1.219

SECONDARY outcome

Timeframe: Baseline up to 10 weeks

Population: Randomized participants with a baseline and at least 1 post-baseline C-SSRS suicidal ideation score during the acute treatment period, whose baseline maximum C-SSRS suicidal ideation score was \<5. Nine (9) participants from 1 site with major quality issues were excluded.

The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)\*100.

Outcome measures

Outcome measures
Measure	Duloxetine (Acute Treatment) n=135 Participants Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.	Placebo (Acute Treatment) n=134 Participants Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)	5.9 percentage of participants	5.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to 10 weeks

Population: Randomized participants with a baseline and at least 1 post-baseline C-SSRS suicidal behavior score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.

The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)\*100.

Outcome measures

Outcome measures
Measure	Duloxetine (Acute Treatment) n=135 Participants Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.	Placebo (Acute Treatment) n=134 Participants Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 10 weeks, 28 weeks

Population: Randomized participants with a PARS severity score for GAD during the acute treatment period and at least 1 PARS severity score for GAD during the extension treatment period, excluding 9 participants from 1 site with major quality issues.

PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline\*visit, and age category\*visit within reporting groups.

Outcome measures

Outcome measures
Measure	Duloxetine (Acute Treatment) n=104 Participants Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.	Placebo (Acute Treatment) n=105 Participants Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Change From 10-Week to 28-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist	-3.33 units on a scale Standard Error 0.352	-5.15 units on a scale Standard Error 0.452

SECONDARY outcome

Timeframe: 10 weeks, 28 weeks

Population: Randomized participants with a PARS severity total score during the acute treatment period and at least 1 PARS severity total score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.

PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline\*visit, and age category\*visit within reporting groups.

Outcome measures

Outcome measures
Measure	Duloxetine (Acute Treatment) n=104 Participants Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.	Placebo (Acute Treatment) n=105 Participants Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Change From 10-Week to 28-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms	-3.32 units on a scale Standard Error 0.357	-5.26 units on a scale Standard Error 0.432

SECONDARY outcome

Timeframe: 10 weeks, 28 weeks

Population: Randomized participants with a CGI-S score during the acute treatment period and at least 1 CGI-S score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.

The CGI-S scale evaluated the severity of mental illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline\*visit, and age category\*visit within reporting groups.

Outcome measures

Outcome measures
Measure	Duloxetine (Acute Treatment) n=104 Participants Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.	Placebo (Acute Treatment) n=105 Participants Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Change From 10-Week to 28-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale	-0.76 units on a scale Standard Error 0.093	-1.17 units on a scale Standard Error 0.088

SECONDARY outcome

Timeframe: 10 weeks, 28 weeks

Population: Randomized participants with a CGAS score during the acute treatment period and at least 1 CGAS score during the extension treatment period \[last observation carried forward (LOCF)\], excluding 9 participants from 1 site with major quality issues.

The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for pooled investigator, baseline, and age category within reporting groups.

Outcome measures

Outcome measures
Measure	Duloxetine (Acute Treatment) n=103 Participants Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.	Placebo (Acute Treatment) n=105 Participants Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Change From 10-Week to 28-Week Endpoint in the Children's Global Assessment Scale (CGAS)	7.32 units on a scale Standard Error 1.19	10.48 units on a scale Standard Error 1.03

SECONDARY outcome

Timeframe: 10 weeks up to 28 weeks

Population: Randomized participants with a C-SSRS suicidal ideation score \<5 at the last 2 visits in the acute treatment period and at least 1 C-SSRS suicidal ideation score during the extension treatment period. Nine (9) participants from 1 site with major quality issues were excluded.

Outcome measures

Outcome measures
Measure	Duloxetine (Acute Treatment) n=104 Participants Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.	Placebo (Acute Treatment) n=105 Participants Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)	3 percentage of participants	3 percentage of participants

SECONDARY outcome

Timeframe: 10 weeks up to 28 weeks

Population: Randomized participants with a C-SSRS suicidal behavior score at the last 2 visits in the acute treatment period and at least 1 C-SSRS suicidal behavior score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.

Outcome measures

Outcome measures
Measure	Duloxetine (Acute Treatment) n=104 Participants Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.	Placebo (Acute Treatment) n=105 Participants Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)	0 percentage of participants	2 percentage of participants

Adverse Events

Duloxetine

Serious events: 1 serious events

Other events: 106 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 90 other events

Deaths: 0 deaths

Duloxetine/Duloxetine-Extension Treatment

Serious events: 2 serious events

Other events: 73 other events

Deaths: 0 deaths

Placebo/Duloxetine-Extension Treatment

Serious events: 2 serious events

Other events: 73 other events

Deaths: 0 deaths

Duloxetine-Taper

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo-Taper

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Duloxetine n=135 participants at risk Adverse events (AEs) during the acute treatment period for participants who received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks.	Placebo n=137 participants at risk AEs during the acute treatment period for participants who received placebo capsules orally, QD for 10 weeks.	Duloxetine/Duloxetine-Extension Treatment n=104 participants at risk AEs during the extension treatment period for participants who received flexible doses of duloxetine 30 to 120 mg orally, QD during both the acute and extension treatment periods (up to 28 weeks).	Placebo/Duloxetine-Extension Treatment n=106 participants at risk AEs during the extension treatment period for participants who received placebo capsules orally, QD during the acute treatment period (10 weeks) and flexible doses of duloxetine 30 to 120 mg orally, QD during the extension treatment period (up to 18 weeks).	Duloxetine-Taper n=97 participants at risk AEs during the taper period for participants who were dispensed duloxetine prior to entering the taper phase. Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period.	Placebo-Taper n=7 participants at risk AEs during the taper period for participants who were dispensed placebo prior to entering the taper phase. Participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.
Infections and infestations Adenoiditis	0.00% 0/135 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/137 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.96% 1/104 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/106 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Infections and infestations Tonsillitis	0.00% 0/135 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/137 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.96% 1/104 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/106 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Psychiatric disorders Acute psychosis	0.00% 0/135 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/137 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/104 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.94% 1/106 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Psychiatric disorders Bipolar disorder	0.00% 0/135 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/137 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/104 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.94% 1/106 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Psychiatric disorders Self-injurious ideation	0.74% 1/135 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/137 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/104 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/106 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Psychiatric disorders Suicidal ideation	0.74% 1/135 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/137 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.96% 1/104 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/106 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.0% 1/97 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	14.3% 1/7 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.

Other adverse events

Other adverse events
Measure	Duloxetine n=135 participants at risk Adverse events (AEs) during the acute treatment period for participants who received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks.	Placebo n=137 participants at risk AEs during the acute treatment period for participants who received placebo capsules orally, QD for 10 weeks.	Duloxetine/Duloxetine-Extension Treatment n=104 participants at risk AEs during the extension treatment period for participants who received flexible doses of duloxetine 30 to 120 mg orally, QD during both the acute and extension treatment periods (up to 28 weeks).	Placebo/Duloxetine-Extension Treatment n=106 participants at risk AEs during the extension treatment period for participants who received placebo capsules orally, QD during the acute treatment period (10 weeks) and flexible doses of duloxetine 30 to 120 mg orally, QD during the extension treatment period (up to 18 weeks).	Duloxetine-Taper n=97 participants at risk AEs during the taper period for participants who were dispensed duloxetine prior to entering the taper phase. Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period.	Placebo-Taper n=7 participants at risk AEs during the taper period for participants who were dispensed placebo prior to entering the taper phase. Participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.
Cardiac disorders Palpitations	4.4% 6/135 • Number of events 6 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/137 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/104 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/106 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Gastrointestinal disorders Abdominal discomfort	2.2% 3/135 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.9% 4/137 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/104 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/106 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.0% 1/97 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Gastrointestinal disorders Abdominal pain upper	9.6% 13/135 • Number of events 15 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	6.6% 9/137 • Number of events 10 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	4.8% 5/104 • Number of events 6 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	6.6% 7/106 • Number of events 7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.1% 2/97 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Gastrointestinal disorders Constipation	3.7% 5/135 • Number of events 6 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.9% 4/137 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/104 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.94% 1/106 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Gastrointestinal disorders Diarrhoea	6.7% 9/135 • Number of events 10 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	4.4% 6/137 • Number of events 6 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.96% 1/104 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	4.7% 5/106 • Number of events 6 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Gastrointestinal disorders Flatulence	0.74% 1/135 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/137 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/104 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.94% 1/106 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	14.3% 1/7 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Gastrointestinal disorders Nausea	20.7% 28/135 • Number of events 35 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	5.8% 8/137 • Number of events 8 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	9.6% 10/104 • Number of events 10 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	12.3% 13/106 • Number of events 16 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.0% 1/97 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Gastrointestinal disorders Vomiting	16.3% 22/135 • Number of events 23 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	7.3% 10/137 • Number of events 10 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	4.8% 5/104 • Number of events 7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	5.7% 6/106 • Number of events 6 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
General disorders Chest pain	2.2% 3/135 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/137 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.96% 1/104 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/106 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
General disorders Fatigue	8.1% 11/135 • Number of events 11 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	4.4% 6/137 • Number of events 6 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	3.8% 4/104 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	8.5% 9/106 • Number of events 9 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
General disorders Irritability	3.0% 4/135 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	4.4% 6/137 • Number of events 6 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	3.8% 4/104 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.8% 3/106 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.0% 1/97 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
General disorders Pyrexia	1.5% 2/135 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.9% 4/137 • Number of events 5 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.9% 2/104 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.9% 2/106 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Infections and infestations Bronchitis	3.0% 4/135 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.9% 4/137 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.9% 2/104 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.94% 1/106 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Infections and infestations Ear infection	0.74% 1/135 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.5% 2/137 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.9% 3/104 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.94% 1/106 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Infections and infestations Gastroenteritis	0.74% 1/135 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.73% 1/137 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.96% 1/104 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.8% 3/106 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.0% 1/97 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Infections and infestations Gastroenteritis viral	3.0% 4/135 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.5% 2/137 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.96% 1/104 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.94% 1/106 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Infections and infestations Influenza	3.0% 4/135 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.2% 3/137 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	5.8% 6/104 • Number of events 6 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	3.8% 4/106 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Infections and infestations Nasopharyngitis	3.0% 4/135 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	8.8% 12/137 • Number of events 13 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	3.8% 4/104 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	4.7% 5/106 • Number of events 5 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Infections and infestations Pharyngitis	2.2% 3/135 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.73% 1/137 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.9% 2/104 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.9% 2/106 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Infections and infestations Pharyngitis streptococcal	0.74% 1/135 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.5% 2/137 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.9% 3/104 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.9% 2/106 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Infections and infestations Sinusitis	0.74% 1/135 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.9% 4/137 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	5.8% 6/104 • Number of events 6 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	4.7% 5/106 • Number of events 5 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Infections and infestations Upper respiratory tract infection	1.5% 2/135 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.9% 4/137 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.9% 3/104 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.9% 2/106 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Infections and infestations Urinary tract infection	0.74% 1/135 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.5% 2/137 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.9% 3/104 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/106 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Investigations Weight decreased	3.7% 5/135 • Number of events 5 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.73% 1/137 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/104 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.9% 2/106 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Investigations Weight increased	1.5% 2/135 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.2% 3/137 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.9% 2/104 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/106 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Metabolism and nutrition disorders Decreased appetite	14.8% 20/135 • Number of events 21 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	5.1% 7/137 • Number of events 7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.96% 1/104 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	8.5% 9/106 • Number of events 10 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Metabolism and nutrition disorders Increased appetite	1.5% 2/135 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.9% 4/137 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/104 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/106 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Nervous system disorders Dizziness	7.4% 10/135 • Number of events 10 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.5% 2/137 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	4.8% 5/104 • Number of events 5 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	6.6% 7/106 • Number of events 9 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.0% 1/97 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Nervous system disorders Headache	20.0% 27/135 • Number of events 37 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	16.8% 23/137 • Number of events 29 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	12.5% 13/104 • Number of events 17 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	10.4% 11/106 • Number of events 13 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	3.1% 3/97 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Nervous system disorders Paraesthesia	0.00% 0/135 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.2% 3/137 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/104 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.9% 2/106 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.0% 1/97 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Nervous system disorders Psychomotor hyperactivity	2.2% 3/135 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.5% 2/137 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.96% 1/104 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.94% 1/106 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Nervous system disorders Sedation	2.2% 3/135 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/137 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/104 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.9% 2/106 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Nervous system disorders Somnolence	11.9% 16/135 • Number of events 16 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	6.6% 9/137 • Number of events 9 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.9% 3/104 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	7.5% 8/106 • Number of events 11 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Nervous system disorders Tremor	3.0% 4/135 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.73% 1/137 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.9% 2/104 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.9% 2/106 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.0% 1/97 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Psychiatric disorders Insomnia	8.9% 12/135 • Number of events 13 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	5.1% 7/137 • Number of events 8 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.96% 1/104 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.8% 3/106 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Psychiatric disorders Intentional self-injury	0.74% 1/135 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.73% 1/137 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.9% 3/104 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.9% 2/106 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Reproductive system and breast disorders Dysmenorrhoea	2.9% 2/70 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.7% 2/75 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/53 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	3.4% 2/59 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/47 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Respiratory, thoracic and mediastinal disorders Cough	4.4% 6/135 • Number of events 6 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/137 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	3.8% 4/104 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	4.7% 5/106 • Number of events 5 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.2% 3/135 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/137 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/104 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/106 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.4% 10/135 • Number of events 10 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.2% 3/137 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.96% 1/104 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	6.6% 7/106 • Number of events 7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.2% 3/135 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.73% 1/137 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.96% 1/104 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.9% 2/106 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Skin and subcutaneous tissue disorders Rash	0.74% 1/135 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	1.5% 2/137 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.96% 1/104 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	3.8% 4/106 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.
Vascular disorders Hot flush	1.5% 2/135 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.73% 1/137 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/104 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	2.8% 3/106 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/97 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.	0.00% 0/7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants, excluding 9 participants from 1 site with major quality issues.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60