Trial Outcomes & Findings for A Study of Fluoxetine in Major Depressive Disorder (MDD) Short-Term Dosing (NCT NCT01808612)

NCT ID: NCT01808612

Last Updated: 2015-05-12

Results Overview

HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 513 participants
• Primary outcome timeframe: Baseline, 6 weeks
• Results posted on: 2015-05-12

Participant Flow

This study consisted of 3 periods: a single-blind screening period (1 week of placebo), a double-blind short-term treatment period (1 week of placebo followed by randomization in a 2:1:3 fashion to 20 milligrams [mg] fluoxetine, 40 mg fluoxetine, or placebo, respectively, for 6 weeks), and a single-blind discontinuation period (2 weeks of placebo).

Participant milestones

Measure	20 mg Fluoxetine Treatment Period: 20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks	40 mg Fluoxetine Treatment Period: 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks	Placebo Treatment Period: placebo (capsules) administered orally, once daily, for 6 weeks Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks
Treatment Period STARTED	169	84	260
Treatment Period Received at Least 1 Dose of Study Drug	168	83	259
Treatment Period COMPLETED	154	77	246
Treatment Period NOT COMPLETED	15	7	14
Discontinuation Period STARTED	87	38	145
Discontinuation Period COMPLETED	85	37	145
Discontinuation Period NOT COMPLETED	2	1	0

Reasons for withdrawal

Measure	20 mg Fluoxetine Treatment Period: 20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks	40 mg Fluoxetine Treatment Period: 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks	Placebo Treatment Period: placebo (capsules) administered orally, once daily, for 6 weeks Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks
Treatment Period Adverse Event	8	4	3
Treatment Period Lost to Follow-up	2	2	1
Treatment Period Protocol Violation	1	0	0
Treatment Period Withdrawal by Subject	1	0	4
Treatment Period Physician Decision	1	0	4
Treatment Period Sponsor Decision	1	0	0
Treatment Period Lack of Efficacy	1	1	2
Discontinuation Period Adverse Event	1	0	0
Discontinuation Period Physician Decision	1	0	0
Discontinuation Period Lost to Follow-up	0	1	0

Baseline Characteristics

A Study of Fluoxetine in Major Depressive Disorder (MDD) Short-Term Dosing

Baseline characteristics by cohort

Measure	20 mg Fluoxetine n=168 Participants 20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	40 mg Fluoxetine n=83 Participants 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	Placebo n=259 Participants Placebo (capsules) administered orally, once daily, for 6 weeks	Total n=510 Participants Total of all reporting groups
Age, Continuous	40.05 years STANDARD_DEVIATION 11.19 • n=93 Participants	39.58 years STANDARD_DEVIATION 10.56 • n=4 Participants	38.54 years STANDARD_DEVIATION 11.65 • n=27 Participants	39.20 years STANDARD_DEVIATION 11.33 • n=483 Participants
Sex: Female, Male Female	83 Participants n=93 Participants	33 Participants n=4 Participants	129 Participants n=27 Participants	245 Participants n=483 Participants
Sex: Female, Male Male	85 Participants n=93 Participants	50 Participants n=4 Participants	130 Participants n=27 Participants	265 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	168 Participants n=93 Participants	83 Participants n=4 Participants	259 Participants n=27 Participants	510 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	168 Participants n=93 Participants	83 Participants n=4 Participants	259 Participants n=27 Participants	510 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment Japan	168 participants n=93 Participants	83 participants n=4 Participants	259 participants n=27 Participants	510 participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline, 6 weeks

Population: Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period.

HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.

Outcome measures

Measure	20 mg Fluoxetine n=168 Participants 20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	40 mg Fluoxetine n=83 Participants 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	Placebo n=259 Participants Placebo (capsules) administered orally, once daily, for 6 weeks
Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score	-6.18 units on a scale Standard Error 0.57	-6.25 units on a scale Standard Error 0.77	-6.91 units on a scale Standard Error 0.49

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Population: Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 subscale score during the Treatment Period.

HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.

Outcome measures

Measure	20 mg Fluoxetine n=168 Participants 20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	40 mg Fluoxetine n=83 Participants 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	Placebo n=259 Participants Placebo (capsules) administered orally, once daily, for 6 weeks
Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores HAMD17 total score	-5.59 units on a scale Standard Error 0.53	-5.61 units on a scale Standard Error 0.71	-6.27 units on a scale Standard Error 0.45
Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores Maier subscale score	-3.35 units on a scale Standard Error 0.30	-3.39 units on a scale Standard Error 0.40	-3.30 units on a scale Standard Error 0.26
Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores Anxiety/Somatization subscale score	-2.04 units on a scale Standard Error 0.21	-1.84 units on a scale Standard Error 0.28	-2.06 units on a scale Standard Error 0.18
Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores Retardation/Somatization subscale score	-2.00 units on a scale Standard Error 0.20	-2.21 units on a scale Standard Error 0.27	-2.23 units on a scale Standard Error 0.17
Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores Sleep subscale score	-0.83 units on a scale Standard Error 0.15	-0.81 units on a scale Standard Error 0.20	-1.10 units on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: up to 6 weeks

Population: Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.

The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.

Outcome measures

Measure	20 mg Fluoxetine n=168 Participants 20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	40 mg Fluoxetine n=83 Participants 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	Placebo n=259 Participants Placebo (capsules) administered orally, once daily, for 6 weeks
Percentage of Participants Achieving a Response at 6-Week Endpoint	23.8 percentage of participants	18.1 percentage of participants	27.8 percentage of participants

SECONDARY outcome

Timeframe: up to 6 weeks

Population: Randomized participants who received at least 1 dose of study drug with a baseline (which had not achieved remission threshold criteria) and had at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.

The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.

Outcome measures

Measure	20 mg Fluoxetine n=168 Participants 20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	40 mg Fluoxetine n=83 Participants 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	Placebo n=258 Participants Placebo (capsules) administered orally, once daily, for 6 weeks
Percentage of Participants Achieving a Remission at 6-Week Endpoint	9.5 percentage of participants	9.6 percentage of participants	15.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Population: Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline CGI-S score during the Treatment Period.

CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.

Outcome measures

Measure	20 mg Fluoxetine n=168 Participants 20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	40 mg Fluoxetine n=83 Participants 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	Placebo n=259 Participants Placebo (capsules) administered orally, once daily, for 6 weeks
Mean Change From Baseline to 6-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale	-0.69 units on a scale Standard Error 0.08	-0.67 units on a scale Standard Error 0.11	-0.81 units on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline, up to 6 weeks

Population: Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline SDS score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only postbaseline data.

SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score.

Outcome measures

Measure	20 mg Fluoxetine n=167 Participants 20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	40 mg Fluoxetine n=81 Participants 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	Placebo n=259 Participants Placebo (capsules) administered orally, once daily, for 6 weeks
Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores Work/School subscale score (n=143, 64, 226)	-0.79 units on a scale Standard Error 0.27	-0.34 units on a scale Standard Error 0.36	-0.88 units on a scale Standard Error 0.24
Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores Social/Leisure subscale score (n=167, 81, 259)	-0.66 units on a scale Standard Error 0.23	-0.81 units on a scale Standard Error 0.30	-0.70 units on a scale Standard Error 0.21
Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores Family/Home subscale score (n=167, 81, 259)	-0.47 units on a scale Standard Error 0.21	-0.30 units on a scale Standard Error 0.28	-0.41 units on a scale Standard Error 0.19
Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores Total score (n=167, 81, 259)	-1.76 units on a scale Standard Error 0.59	-1.55 units on a scale Standard Error 0.78	-1.99 units on a scale Standard Error 0.53

SECONDARY outcome

Timeframe: Baseline through 6 weeks

Population: Randomized participants who received at least 1 dose of study drug with at least 1 post-baseline C-SSRS score during the Treatment Period.

C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.

Outcome measures

Measure	20 mg Fluoxetine n=168 Participants 20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	40 mg Fluoxetine n=83 Participants 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks	Placebo n=259 Participants Placebo (capsules) administered orally, once daily, for 6 weeks
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) Suicidal behavior	0 participants	0 participants	1 participants
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) Suicidal ideation	5 participants	6 participants	8 participants

Adverse Events

Placebo (Treatment Period)

Serious events: 2 serious events

Other events: 75 other events

Deaths: 0 deaths

20 mg Fluoxetine (Treatment Period)

Serious events: 0 serious events

Other events: 49 other events

Deaths: 0 deaths

40 mg Fluoxetine (Treatment Period)

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Placebo (Discontinuation From Placebo)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo (Discontinuation From 20 mg Fluoxetine)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo (Discontinuation From 40 mg Fluoxetine)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo (Treatment Period) n=259 participants at risk Adverse events (AEs) which occurred during the Treatment Period for participants who received placebo administered orally, once daily, for 6 weeks during the Treatment Period	20 mg Fluoxetine (Treatment Period) n=168 participants at risk AEs which occurred during the Treatment Period for participants who received 20 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period	40 mg Fluoxetine (Treatment Period) n=83 participants at risk AEs which occurred during the Treatment Period for participants who received 40 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period	Placebo (Discontinuation From Placebo) n=145 participants at risk AEs which occurred during the Discontinuation Period for participants who received placebo during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period	Placebo (Discontinuation From 20 mg Fluoxetine) n=87 participants at risk AEs which occurred during the Discontinuation Period for participants who received 20 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period	Placebo (Discontinuation From 40 mg Fluoxetine) n=38 participants at risk AEs which occurred during the Discontinuation Period for participants who received 40 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
Gastrointestinal disorders Colitis ulcerative	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.69% 1/145 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Suicide attempt	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Infertility male	0.77% 1/130 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/85 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/50 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.

Other adverse events

Measure	Placebo (Treatment Period) n=259 participants at risk Adverse events (AEs) which occurred during the Treatment Period for participants who received placebo administered orally, once daily, for 6 weeks during the Treatment Period	20 mg Fluoxetine (Treatment Period) n=168 participants at risk AEs which occurred during the Treatment Period for participants who received 20 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period	40 mg Fluoxetine (Treatment Period) n=83 participants at risk AEs which occurred during the Treatment Period for participants who received 40 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period	Placebo (Discontinuation From Placebo) n=145 participants at risk AEs which occurred during the Discontinuation Period for participants who received placebo during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period	Placebo (Discontinuation From 20 mg Fluoxetine) n=87 participants at risk AEs which occurred during the Discontinuation Period for participants who received 20 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period	Placebo (Discontinuation From 40 mg Fluoxetine) n=38 participants at risk AEs which occurred during the Discontinuation Period for participants who received 40 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
Renal and urinary disorders Pollakiuria	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Proteinuria	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Dysmenorrhoea	0.78% 1/129 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/33 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Ejaculation delayed	0.00% 0/130 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/85 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	2.0% 1/50 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Atrioventricular block first degree	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Palpitations	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Tachycardia	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Sudden hearing loss	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Tinnitus	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Endocrine disorders Hyperthyroidism	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Endocrine disorders Thyroiditis	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Eye disorders Vision blurred	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.77% 2/259 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	1.9% 5/259 • Number of events 5 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dental caries	1.2% 3/259 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 2/168 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	1.2% 3/259 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 2/168 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.1% 1/87 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dyspepsia	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Enteritis	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastritis	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastritis atrophic	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gingival inflammation	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Irritable bowel syndrome	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	3.0% 5/168 • Number of events 5 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	4.8% 4/83 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Stomatitis	1.2% 3/259 • Number of events 4 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.77% 2/259 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	2.6% 1/38 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
General disorders Malaise	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 2/168 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
General disorders Oedema peripheral	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
General disorders Swelling	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
General disorders Thirst	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Hepatobiliary disorders Alcoholic liver disease	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Hepatobiliary disorders Hepatic function abnormal	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Infections and infestations Enterocolitis bacterial	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Infections and infestations Gastroenteritis	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	3.6% 3/83 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Infections and infestations Gastroenteritis viral	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	2.6% 1/38 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Infections and infestations Gingivitis	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.1% 1/87 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Infections and infestations Influenza	0.77% 2/259 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	6.6% 17/259 • Number of events 17 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	3.6% 6/168 • Number of events 7 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	4.8% 4/83 • Number of events 5 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	2.1% 3/145 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Infections and infestations Oral herpes	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Infections and infestations Pharyngitis	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Infections and infestations Sinusitis	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Accidental overdose	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Contusion	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Hand fracture	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Heat illness	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Thermal burn	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	1.2% 3/259 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 2/168 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.1% 1/87 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.69% 1/145 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Blood creatine phosphokinase increased	0.77% 2/259 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	3.6% 6/168 • Number of events 6 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Blood thyroid stimulating hormone decreased	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Blood triglycerides increased	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Blood urine present	0.77% 2/259 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Electrocardiogram qt prolonged	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Electrocardiogram st segment depression	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Endoscopy large bowel	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Gamma-glutamyltransferase increased	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Hepatic enzyme increased	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Liver function test abnormal	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Neutrophil count decreased	0.77% 2/259 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Protein urine	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Qrs axis abnormal	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 2/168 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Urine ketone body present	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations Weight decreased	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.8% 3/168 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Investigations White blood cell count decreased	1.2% 3/259 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 2/168 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypercreatininaemia	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthritis	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	1.2% 3/259 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Joint swelling	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Duodenal neoplasm	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Amnesia	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Anterograde amnesia	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Dysgeusia	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Headache	0.77% 2/259 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 2/168 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	2.3% 2/87 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Somnolence	0.77% 2/259 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	3.6% 6/168 • Number of events 6 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Tremor	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Depression	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Impatience	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Insomnia	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Irritability	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Major depression	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.8% 3/168 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Restlessness	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Suicidal ideation	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.69% 1/145 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Eczema	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.60% 1/168 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Miliaria	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/83 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.1% 1/87 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.39% 1/259 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.8% 3/168 • Number of events 3 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	2.4% 2/83 • Number of events 2 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.69% 1/145 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
Vascular disorders Orthostatic hypotension	0.00% 0/259 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/168 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	1.2% 1/83 • Number of events 1 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/145 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/87 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.	0.00% 0/38 Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.

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