Trial Outcomes & Findings for An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis (NCT NCT00463151)

NCT ID: NCT00463151

Last Updated: 2021-07-20

Results Overview

Definition of clinical improvement: a decrease of Disease Activity Index \[DAI\] score for "rectal bleeding" to either 0 or 1 point and a decrease of ≥1 point in the DAI score for "findings on endoscopy" from the baseline

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 124 participants
• Primary outcome timeframe: Week 6
• Results posted on: 2021-07-20

Participant Flow

Participant milestones

Measure	Rebamipide 60 mg Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Rebamipide 150 mg Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Rebamipide 300 mg Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Placebo Once daily intracolonial administration of placebo for 6 weeks
Overall Study STARTED	35	29	29	31
Overall Study COMPLETED	33	24	26	24
Overall Study NOT COMPLETED	2	5	3	7

Reasons for withdrawal

Measure	Rebamipide 60 mg Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Rebamipide 150 mg Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Rebamipide 300 mg Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Placebo Once daily intracolonial administration of placebo for 6 weeks
Overall Study Adverse Event	0	0	1	0
Overall Study Lack of Efficacy	2	5	2	5
Overall Study Protocol Violation	0	0	0	1
Overall Study Withdrawal by Subject	0	0	0	1

Baseline Characteristics

An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

Baseline characteristics by cohort

Measure	Rebamipide 60 mg n=35 Participants Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Rebamipide 150 mg n=29 Participants Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Rebamipide 300 mg n=27 Participants Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Placebo n=30 Participants Once daily intracolonial administration of placebo for 6 weeks	Total n=121 Participants Total of all reporting groups
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	34 Participants n=5 Participants	26 Participants n=7 Participants	25 Participants n=5 Participants	28 Participants n=4 Participants	113 Participants n=21 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	16 Participants n=7 Participants	8 Participants n=5 Participants	14 Participants n=4 Participants	52 Participants n=21 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants	16 Participants n=4 Participants	69 Participants n=21 Participants
Region of Enrollment Japan	35 Participants n=5 Participants	29 Participants n=7 Participants	27 Participants n=5 Participants	30 Participants n=4 Participants	121 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 6

Population: Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained

Definition of clinical improvement: a decrease of Disease Activity Index [DAI] score for "rectal bleeding" to either 0 or 1 point and a decrease of ≥1 point in the DAI score for "findings on endoscopy" from the baseline

Outcome measures

Measure	Rebamipide 60 mg n=35 Participants Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Rebamipide 150 mg n=29 Participants Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Rebamipide 300 mg n=27 Participants Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Placebo n=30 Participants Once daily intracolonial administration of placebo for 6 weeks
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100)	31.4 percentage of participants Interval 16.0 to 46.8	24.1 percentage of participants Interval 8.6 to 39.7	44.4 percentage of participants Interval 25.7 to 63.2	30.0 percentage of participants Interval 13.6 to 46.4

SECONDARY outcome

Timeframe: Week 6

Population: Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained

Definition of remission: a decrease of the total DAI scores for "rectal bleeding" and "findings on endoscopy" to 0 points

Outcome measures

Measure	Rebamipide 60 mg n=35 Participants Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Rebamipide 150 mg n=29 Participants Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Rebamipide 300 mg n=27 Participants Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Placebo n=30 Participants Once daily intracolonial administration of placebo for 6 weeks
Clinical Remission (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100)	2.9 percentage of participants Interval 0.0 to 8.4	0.0 percentage of participants Interval 0.0 to 0.0	18.5 percentage of participants Interval 3.9 to 33.2	3.3 percentage of participants Interval 0.0 to 9.8

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained

DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment. Each item of the score is assessed on a 4-point scale from 0 to 3; the total score ranges from 0 to 12 with a higher score representing greater severity. A negative change in mean score indicates improvement.

Outcome measures

Measure	Rebamipide 60 mg n=33 Participants Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Rebamipide 150 mg n=26 Participants Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Rebamipide 300 mg n=26 Participants Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Placebo n=27 Participants Once daily intracolonial administration of placebo for 6 weeks
Mean Change From Baseline in Total DAI Score	-2.5 score on a scale Standard Deviation 2.5	-1.6 score on a scale Standard Deviation 2.6	-3.0 score on a scale Standard Deviation 3.0	-2.0 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline and week 6

Population: Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained

DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment. Each item of the score is assessed on a 4-point scale from 0 to 3 with a higher score representing greater severity. A negative change from baseline indicates improvement.

Outcome measures

Measure	Rebamipide 60 mg n=35 Participants Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Rebamipide 150 mg n=29 Participants Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Rebamipide 300 mg n=27 Participants Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Placebo n=30 Participants Once daily intracolonial administration of placebo for 6 weeks
Percentage of Subjects Showing Improvement in Each DAI Subscore Rectal bleeding	65.7 percentage of participants	51.7 percentage of participants	66.7 percentage of participants	63.3 percentage of participants
Percentage of Subjects Showing Improvement in Each DAI Subscore Stool frequency	48.6 percentage of participants	31.0 percentage of participants	59.3 percentage of participants	10.0 percentage of participants
Percentage of Subjects Showing Improvement in Each DAI Subscore Findings on endoscopy	39.4 percentage of participants	26.9 percentage of participants	53.8 percentage of participants	48.1 percentage of participants
Percentage of Subjects Showing Improvement in Each DAI Subscore Physician's global assessment	48.6 percentage of participants	31.0 percentage of participants	51.9 percentage of participants	36.70 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained

The index consisted of 4 subscales: granulation scattering reflected light, vascular pattern, vulnerability of mucosa, and mucosal damage. Each subscale was scored on a scale of 0 to 4 and the total score (the sum of all 4 subscores) ranges from 0 to 12, higher scores indicate more severe disease.

Outcome measures

Measure	Rebamipide 60 mg n=33 Participants Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Rebamipide 150 mg n=26 Participants Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Rebamipide 300 mg n=26 Participants Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Placebo n=27 Participants Once daily intracolonial administration of placebo for 6 weeks
Mean Change From Baseline in Total Endoscopic Index (EI) Score	-1.6 score on a scale Standard Deviation 2.2	-1.2 score on a scale Standard Deviation 2.5	-2.4 score on a scale Standard Deviation 2.9	-1.9 score on a scale Standard Deviation 2.4

Adverse Events

Rebamipide 60 mg

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Rebamipide 150 mg

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Rebamipide 300 mg

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rebamipide 60 mg n=35 participants at risk Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Rebamipide 150 mg n=29 participants at risk Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Rebamipide 300 mg n=29 participants at risk Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Placebo n=31 participants at risk Once daily intracolonial administration of placebo for 6 weeks
Gastrointestinal disorders Colitis ulcerative	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Infections and infestations Necrotising fasciitis	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Ear and labyrinth disorders Vertigo positional	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.

Other adverse events

Measure	Rebamipide 60 mg n=35 participants at risk Once daily intracolonial administration at a dose of 60 mg for 6 weeks	Rebamipide 150 mg n=29 participants at risk Once daily intracolonial administration at a dose of 150 mg for 6 weeks	Rebamipide 300 mg n=29 participants at risk Once daily intracolonial administration at a dose of 300 mg for 6 weeks	Placebo n=31 participants at risk Once daily intracolonial administration of placebo for 6 weeks
Nervous system disorders Somnolence	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Psychiatric disorders Depression	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Musculoskeletal and connective tissue disorders Muscle tightness	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Nervous system disorders Dizziness	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Nervous system disorders Dysgeusia	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Nervous system disorders Headache	8.6% 3/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	10.3% 3/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Nervous system disorders Migraine	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Cardiac disorders Tachycardia	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Eye disorders Asthenopia	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Gastrointestinal disorders Abdominal distension	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Gastrointestinal disorders Cheilitis	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	6.5% 2/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Gastrointestinal disorders Colitis ulcerative	5.7% 2/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	20.7% 6/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Gastrointestinal disorders Constipation	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Gastrointestinal disorders Diarrhoea	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Gastrointestinal disorders Gastritis	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Gastrointestinal disorders Pancreatitis	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Gastrointestinal disorders Stomach discomfort	5.7% 2/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Gastrointestinal disorders Haemorrhoidal haemorrhage	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Gastrointestinal disorders Rectal tenesmus	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	9.7% 3/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
General disorders Feeling hot	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
General disorders Malaise	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
General disorders Pyrexia	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Hepatobiliary disorders Hepatic function abnormal	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	10.3% 3/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Immune system disorders Food allergy	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Immune system disorders Seasonal allergy	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Infections and infestations Furuncle	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Infections and infestations Herpes simplex	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Infections and infestations Hordeolum	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Infections and infestations Nasopharyngitis	11.4% 4/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	10.3% 3/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	10.3% 3/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	12.9% 4/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Infections and infestations Upper respiratory tract infection	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Infections and infestations Urinary tract infection	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Infections and infestations Enteritis infectious	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Injury, poisoning and procedural complications Contusion	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Alanine aminotransferase increased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	10.3% 3/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Aspartate aminotransferase increased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	6.5% 2/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Basophil count increased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	6.9% 2/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Blood albumin decreased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Blood cholesterol increased	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Blood lactate dehydrogenase increased	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	6.5% 2/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Blood potassium decreased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	6.5% 2/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Blood potassium increased	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Blood pressure increased	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	6.9% 2/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	6.5% 2/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Blood triglycerides increased	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Blood urea decreased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Blood uric acid increased	5.7% 2/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Eosinophil count decreased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Eosinophil count increased	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	10.3% 3/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Gamma-glutamyltransferase increased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Glucose urine present	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Haematocrit decreased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Blood urine present	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	6.9% 2/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Haemoglobin decreased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Liver function test abnormal	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Lymphocyte count abnormal	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Lymphocyte count decreased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Monocyte count increased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Neutrophil count decreased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Neutrophil count increased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Red blood cell count decreased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Red blood cell count increased	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations White blood cell count decreased	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations White blood cell count increased	8.6% 3/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	10.3% 3/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	12.9% 4/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations White blood cells urine positive	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Platelet count increased	5.7% 2/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	6.9% 2/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	6.5% 2/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Protein urine present	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	6.9% 2/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Urine ketone body present	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Investigations Blood alkaline phosphatase increased	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Metabolism and nutrition disorders Diabetes mellitus	2.9% 1/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Psychiatric disorders Insomnia	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	6.5% 2/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Skin and subcutaneous tissue disorders Acne	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.2% 1/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/35 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	3.4% 1/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/29 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.	0.00% 0/31 • Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks Safety Set comprised subjects who received the study drug at least once.

Additional Information

Director of Clinical Trials

Otsuka Pharmaceutical Co., LTD.

Phone: +81-3-6361-7366

Email: CL_OPCJ_RDA_Team@otsuka.jp

Results disclosure agreements

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