Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis (NCT NCT04303195)

NCT ID: NCT04303195

Last Updated: 2025-08-28

Results Overview

Change from Baseline at Weeks 7 through 12 (average) as measured by the Diabetic and Idiopathic Gastroparesis Symptoms Daily Diary (DIGS-DD). Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period, a participant's score for that week was the mean of the daily scores for that week. A negative change from baseline indicates improvement.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 161 participants
• Primary outcome timeframe: Baseline to Week 12
• Results posted on: 2025-08-28

Participant Flow

Participants with symptomatic idiopathic or diabetic gastroparesis took part in the study at 51 investigative sites in the United States from 01 August 2020 to 25 February 2023

Participants eligible for the study were randomized in a 1:1:1:1 ratio to receive either NG101 treatment arms of 5 mg, 10 mg, or 20 mg, or matching placebo during a 12-week Treatment Period. Randomization was stratified on the following factors: gastroparesis etiology (diabetes vs idiopathic), sex (male vs female), and current cannabinoid use (yes vs no).

Participant milestones

Measure	NG101 - 5 mg NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 10 mg NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 20 mg NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	Placebo Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules
Overall Study STARTED	40	41	40	40
Overall Study COMPLETED	35	35	31	33
Overall Study NOT COMPLETED	5	6	9	7

Reasons for withdrawal

Measure	NG101 - 5 mg NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 10 mg NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 20 mg NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	Placebo Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules
Overall Study Adverse Event	1	3	7	0
Overall Study Lost to Follow-up	1	0	1	4
Overall Study Withdrawal by Subject	3	1	1	1
Overall Study No study drug administered or protocol deviation	0	2	0	2

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis

Baseline characteristics by cohort

Measure	NG101 - 5 mg n=40 Participants NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 10 mg n=41 Participants NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 20 mg n=40 Participants NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	Placebo n=40 Participants Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules	Total n=161 Participants Total of all reporting groups
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	32 Participants n=7 Participants	30 Participants n=5 Participants	29 Participants n=4 Participants	123 Participants n=21 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	38 Participants n=21 Participants
Age, Continuous	52.7 years STANDARD_DEVIATION 11.5 • n=5 Participants	53.7 years STANDARD_DEVIATION 11.26 • n=7 Participants	55.7 years STANDARD_DEVIATION 13.50 • n=5 Participants	55.4 years STANDARD_DEVIATION 14.19 • n=4 Participants	54.5 years STANDARD_DEVIATION 12.62 • n=21 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	34 Participants n=7 Participants	33 Participants n=5 Participants	33 Participants n=4 Participants	133 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	28 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	16 Participants n=4 Participants	73 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	24 Participants n=4 Participants	88 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants	23 Participants n=21 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	32 Participants n=7 Participants	33 Participants n=5 Participants	30 Participants n=4 Participants	134 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	40 participants n=5 Participants	41 participants n=7 Participants	40 participants n=5 Participants	40 participants n=4 Participants	161 participants n=21 Participants
Gastroparesis etiology Diabetic	18 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	17 Participants n=4 Participants	73 Participants n=21 Participants
Gastroparesis etiology Idiopathic	22 Participants n=5 Participants	22 Participants n=7 Participants	21 Participants n=5 Participants	23 Participants n=4 Participants	88 Participants n=21 Participants
Cannabinoid use Yes	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	15 Participants n=21 Participants
Cannabinoid use No	36 Participants n=5 Participants	38 Participants n=7 Participants	37 Participants n=5 Participants	35 Participants n=4 Participants	146 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: Per Protocol population included all participants in the Intent-To-Treat Population (all enrolled participants who were randomized) who do not have any major protocol deviations that would affect efficacy as determined by the study team.

Change from Baseline at Weeks 7 through 12 (average) as measured by the Diabetic and Idiopathic Gastroparesis Symptoms Daily Diary (DIGS-DD). Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period, a participant's score for that week was the mean of the daily scores for that week. A negative change from baseline indicates improvement.

Outcome measures

Measure	NG101 - 5 mg n=37 Participants NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 10 mg n=33 Participants NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 20 mg n=33 Participants NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	Placebo n=33 Participants Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules
Change From Baseline of Nausea Severity Score	-3.55 units on a scale Standard Error 0.331	-3.65 units on a scale Standard Error 0.0348	-3.43 units on a scale Standard Error 0.348	-2.83 units on a scale Standard Error 0.347

SECONDARY outcome

Timeframe: Baseline to Week 12

Change from baseline at Weeks 7 through 12 (average) as measured by the Diabetic and Idiopathic Gastroparesis Symptoms Daily Diary (DIGS-DD) for early satiety severity score.

Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period, a participant's score for that week was the mean of the daily scores for that week. A negative change from baseline indicates improvement.

Outcome measures

Measure	NG101 - 5 mg n=37 Participants NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 10 mg n=33 Participants NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 20 mg n=33 Participants NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	Placebo n=33 Participants Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules
Change From Baseline in Early Satiety Severity Score	-3.02 units on a scale Standard Error 0.343	-3.23 units on a scale Standard Error 0.360	-2.64 units on a scale Standard Error 0.362	-2.89 units on a scale Standard Error 0.361

SECONDARY outcome

Timeframe: Baseline to Week 12

Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for postprandial fullness severity score.

Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period. A negative change from baseline indicates improvement.

Outcome measures

Measure	NG101 - 5 mg n=37 Participants NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 10 mg n=33 Participants NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 20 mg n=33 Participants NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	Placebo n=33 Participants Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules
Change From Baseline in Postprandial Fullness Severity Score	-2.94 units on a scale Standard Error 0.373	-2.96 units on a scale Standard Error 0.392	-2.67 units on a scale Standard Error 0.393	-2.87 units on a scale Standard Error 0.394

SECONDARY outcome

Timeframe: Baseline to Week 12

Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for postprandial fullness severity score.

Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period. A negative change from baseline indicates improvement.

Outcome measures

Measure	NG101 - 5 mg n=37 Participants NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 10 mg n=33 Participants NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 20 mg n=33 Participants NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	Placebo n=33 Participants Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules
Change From Baseline in Abdominal Pain Severity Score	-2.65 units on a scale Standard Error 0.280	-2.69 units on a scale Standard Error 0.292	-2.19 units on a scale Standard Error 0.293	-2.70 units on a scale Standard Error 0.295

SECONDARY outcome

Timeframe: Baseline to Week 12

Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for the number of discrete episodes of vomiting.

Participants were asked to record the number of episodes of vomiting in the past 24 hours. Each episode counts as "1". A negative change from baseline indicates improvement.

Outcome measures

Measure	NG101 - 5 mg n=37 Participants NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 10 mg n=33 Participants NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 20 mg n=33 Participants NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	Placebo n=33 Participants Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules
Change From Baseline in Discrete Episodes of Vomiting	-0.42 units on a scale Standard Error 0.081	-0.50 units on a scale Standard Error 0.085	-0.40 units on a scale Standard Error 0.085	-0.31 units on a scale Standard Error 0.085

SECONDARY outcome

Timeframe: Baseline to Week 12

Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for 3-symptom severity score.

Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week, the 3-symptom severity score is the average of the mean daily scores of nausea, early satiety, and postprandial fullness severity scores. A negative change from baseline indicates improvement.

Outcome measures

Measure	NG101 - 5 mg n=37 Participants NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 10 mg n=33 Participants NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 20 mg n=33 Participants NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	Placebo n=33 Participants Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules
Change From Baseline in 3-symptom Severity Score	-3.16 units on a scale Standard Error 0.334	-3.28 units on a scale Standard Error 0.351	-2.92 units on a scale Standard Error 0.352	-2.85 units on a scale Standard Error 0.352

SECONDARY outcome

Timeframe: Baseline to Week 12

Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for 4-symptom severity score.

Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week, the 4-symptom severity score is the average of the mean daily scores of nausea, early satiety, postprandial fullness, and abdominal pain severity scores. A negative change from baseline indicates improvement

Outcome measures

Measure	NG101 - 5 mg n=37 Participants NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 10 mg n=33 Participants NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 20 mg n=33 Participants NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	Placebo n=33 Participants Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules
Change From Baseline in 4-symptom Severity Score	-3.04 units on a scale Standard Error 0.306	-3.14 units on a scale Standard Error 0.321	-2.74 units on a scale Standard Error 0.322	-2.81 units on a scale Standard Error 0.321

Adverse Events

NG101 - 5 mg

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

NG101 - 10 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

NG101 - 20 mg

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	NG101 - 5 mg n=40 participants at risk NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 10 mg n=41 participants at risk NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 20 mg n=40 participants at risk NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	Placebo n=40 participants at risk Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules
Metabolism and nutrition disorders Diabetic ketoacidosis	2.5% 1/40 • Number of events 1 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • Number of events 1 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.

Other adverse events

Measure	NG101 - 5 mg n=40 participants at risk NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 10 mg n=41 participants at risk NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	NG101 - 20 mg n=40 participants at risk NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	Placebo n=40 participants at risk Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules
Reproductive system and breast disorders Breast cyst	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Reproductive system and breast disorders Breast mass	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Nervous system disorders Dizziness	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Nervous system disorders Migraine	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	5.0% 2/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Nervous system disorders Presyncope	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Nervous system disorders Sinus headache	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Nervous system disorders Somnolence	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Nervous system disorders Syncope	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Psychiatric disorders Anxiety	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Psychiatric disorders Depression	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Psychiatric disorders Insomnia	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Renal and urinary disorders Ketonuria	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Reproductive system and breast disorders Benign prostatic hyperplasia	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Reproductive system and breast disorders Galactorrhoea	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Reproductive system and breast disorders Vaginal haemorrhage	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Vascular disorders Haematoma	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Vascular disorders Hypertension	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Vascular disorders Orthostatic hypotension	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Blood and lymphatic system disorders Anaemia	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Cardiac disorders Palpitations	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Cardiac disorders Postural orthostatic tachycardia syndrome	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	5.0% 2/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Cardiac disorders Tachycrdia	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Gastrointestinal disorders Abdominal distension	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Gastrointestinal disorders Abdominal pain upper	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Gastrointestinal disorders Constipation	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	7.5% 3/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Gastrointestinal disorders Diarrhoea	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	5.0% 2/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Gastrointestinal disorders Dry mouth	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Gastrointestinal disorders Dyspepsia	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Gastrointestinal disorders Nausea	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	10.0% 4/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
General disorders Asthenia	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
General disorders Oedema peripheral	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Infections and infestations Bronchitis	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Infections and infestations COVID-19	5.0% 2/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Infections and infestations Coronavirus infection	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	4.9% 2/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Infections and infestations Helicobacter infection	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Infections and infestations Laryngitis	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Infections and infestations Otitis media	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Infections and infestations Pharyngitis	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Infections and infestations Postoperative wound infection	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Infections and infestations Pustle	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Infections and infestations Sinusitis	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	5.0% 2/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Infections and infestations Upper respiratory tract infection	5.0% 2/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Infections and infestations Urinary tract infection	7.5% 3/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	7.3% 3/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	7.5% 3/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Investigations Alanine aminotransferase increased	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Investigations Electrocardiogram QT prolonged	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Investigations Glycosylated haemoglobin increased	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Investigations Hepatic enzyme increased	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Investigations Transaminases increased	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.4% 1/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Musculoskeletal and connective tissue disorders Pain in extremity	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/41 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	2.5% 1/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.	0.00% 0/40 • From study start (randomization) through the End of Study/Safety Visit (approximately 14 weeks) All AEs ad SAEs were collected starting from signature of ICF until the End of Study/Safety Follow-up Visit. Note that in the placebo arm, 40 participants were randomized and included in the intent-to-treat efficacy analyses, but only 39 participants received at least one dose of placebo. Data is provided for all 40 randomized participants.

Additional Information

Chief Scientific Officer

Neurogastrx

Phone: 17817304040

Email: info@neurogastrx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place