Trial Outcomes & Findings for Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN) (NCT NCT04950127)

Last Updated: 2025-07-22

Results Overview

Itch Scores were assessed using a NRS twice daily, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The worst daily itch score was defined as the worst of the two scores recorded daily. The weekly itch score was defined as the average of the worst daily itch scores in one week. The monthly itch score was defined as the worst weekly itch score for the month (4 weeks). Higher monthly itch scores indicate worse itching. Baseline is the worst weekly itch score in the 28 days prior to randomization (Day 1). Change from Baseline is defined as the post dose value minus baseline value. Least-squares (LS) means and the corresponding 95% confidence intervals are reported by taking average of LS means of change from baseline in monthly itch scores obtained over 24 weeks using equal weighting for all time points. Analyzed using Mixed Model Repeated Measures (MMRM) method.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

238 participants

Primary outcome timeframe

Baseline and up to Week 24

Results posted on

2025-07-22

Participant Flow

A total of 238 participants from Europe, North America, Latin America and Asia were enrolled and randomized.

This study was conducted in 2 parts: Part A and Part B. Participants were randomized in 1:1:1:1 ratio to receive either: linerixibat 40 milligram (mg) twice a day (BID) in Part A and Part B, linerixibat 40mg twice a day (BID) in Part A and placebo in Part B, placebo in Part A and Part B, or placebo in Part A and linerixibat 40mg twice a day (BID) in Part B.

Participant milestones

Participant milestones
Measure	Part A: Linerixibat 40 Milligrams (mg) Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part A: Placebo Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).	Part B: Placebo in Part A and Part B Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, continued to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.	Part B: Placebo in Part A and Linerixibat 40 mg in Part B Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, switched to receive linerixibat 40 mg tablet orally twice a day (BID) (from Week 24 to Week 32) in Part B.	Part B: Linerixibat 40 mg in Part A and Placebo in Part B Participants who were randomized to receive linerixibat 40 mg tablet orally BID (up to Week 24) in Part A, switched to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.	Part B: Linerixibat 40 mg in Part A and Part B Participants who were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) (up to Week 24) in Part A, continued to receive linerixibat 40 mg twice a day (BID) (from Week 24 to Week 32) in Part B.
Part A (Day 1 to Week 24) STARTED	119	119	0	0	0	0
Part A (Day 1 to Week 24) Safety Population	119	118	0	0	0	0
Part A (Day 1 to Week 24) COMPLETED	103	108	0	0	0	0
Part A (Day 1 to Week 24) NOT COMPLETED	16	11	0	0	0	0
Part B (Week 24 to Week 32) STARTED	0	0	55	53	49	54
Part B (Week 24 to Week 32) Safety Population	0	0	53	52	46	45
Part B (Week 24 to Week 32) COMPLETED	0	0	55	53	49	49
Part B (Week 24 to Week 32) NOT COMPLETED	0	0	0	0	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Linerixibat 40 Milligrams (mg) Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part A: Placebo Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).	Part B: Linerixibat 40 mg in Part A and Part B Participants who were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) (up to Week 24) in Part A, continued to receive linerixibat 40 mg twice a day (BID) (from Week 24 to Week 32) in Part B.
Part A (Day 1 to Week 24) Adverse Event	4	2	0
Part A (Day 1 to Week 24) Physician Decision	3	2	0
Part A (Day 1 to Week 24) Withdrawal by Subject	9	7	0
Part B (Week 24 to Week 32) Withdrawal by Subject	0	0	4
Part B (Week 24 to Week 32) Physician Decision	0	0	1

Baseline Characteristics

Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Linerixibat 40 Milligrams (mg) n=119 Participants Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part A: Placebo n=119 Participants Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).	Total n=238 Participants Total of all reporting groups
Age, Customized 18-49 Years	42 Participants n=5 Participants	30 Participants n=7 Participants	72 Participants n=5 Participants
Age, Customized 50-64 Years	52 Participants n=5 Participants	54 Participants n=7 Participants	106 Participants n=5 Participants
Age, Customized >=65 Years	25 Participants n=5 Participants	35 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	113 Participants n=7 Participants	226 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized HISPANIC OR LATINO	33 Participants n=5 Participants	21 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized NOT HISPANIC OR LATINO	85 Participants n=5 Participants	95 Participants n=7 Participants	180 Participants n=5 Participants
Race/Ethnicity, Customized UNKNOWN	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and up to Week 24

Population: The analysis was performed on the Intent to Treat (ITT) set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized.

Outcome measures

Outcome measures
Measure	Part A: Linerixibat 40 Milligrams (mg) n=119 Participants Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part A: Placebo n=118 Participants Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).
Part A: Mean Change From Baseline in Monthly Itch Scores Over 24 Weeks Using Numerical Rating Scale (NRS)	-2.86 Scores on a scale Interval -3.23 to -2.5	-2.15 Scores on a scale Interval -2.51 to -1.78

SECONDARY outcome

Timeframe: Baseline and at Week 2

Population: The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Only participants with data at baseline and at least one post-baseline time point were included

Itch Score was assessed using a twice daily NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The worst daily itch score was defined as the worst of the two scores recorded daily. The weekly itch score was defined as the average of the worst daily itch scores in one week. Higher weekly itch scores indicate worse itching. Baseline is the average of the Worst Daily Itch scores in the 7 days prior to randomization (Day 1). Change from Baseline is defined as the Week 2 value minus baseline value. Key secondary endpoints were tested in a step-down/hierarchical approach. Mean Change from Baseline in Weekly Itch Score at Week 2 was the first endpoint tested in the hierarchical analysis. LS mean and the corresponding 95% confidence intervals are reported using Mixed Model Repeated Measures (MMRM) method.

Outcome measures

Outcome measures
Measure	Part A: Linerixibat 40 Milligrams (mg) n=117 Participants Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part A: Placebo n=116 Participants Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).
Part A: Mean Change From Baseline in Weekly Itch Score at Week 2 Using NRS	-1.78 Scores on a scale Interval -2.08 to -1.48	-1.07 Scores on a scale Interval -1.37 to -0.77

SECONDARY outcome

Timeframe: Baseline up to Week 24

Sleep Scores were assessed using an NRS scale, ranging from 0 to 10, where 0 represents no sleep interference and 10 is complete sleep interference. The weekly sleep scale is the average of the daily sleep scores for each week. The monthly sleep score was defined as the worst weekly sleep score for the month (4 weeks). Higher monthly sleep scores indicate higher impact on sleep. Baseline is the worst Weekly Sleep Score in the 28 days prior to randomization (Day 1). Change from Baseline is defined as the post dose value minus baseline value. LS means and the corresponding 95% confidence intervals are reported by taking average of LS means of change from baseline in monthly sleep scores obtained over 24 weeks using equal weighting for all time points analyzed using Mixed Model Repeated Measures (MMRM) method. Mean Change from Baseline in Monthly Sleep Score over 24 weeks was the second endpoint tested in the hierarchical analysis.

Outcome measures

Outcome measures
Measure	Part A: Linerixibat 40 Milligrams (mg) n=119 Participants Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part A: Placebo n=118 Participants Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).
Part A: Mean Change From Baseline in Monthly Sleep Score Over 24 Weeks Using NRS	-2.77 Scores on a scale Interval -3.15 to -2.38	-2.24 Scores on a scale Interval -2.62 to -1.86

SECONDARY outcome

Timeframe: At Week 24

Population: The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Percentage values were rounded to the nearest whole number.

Monthly Itch Score was assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The Monthly Itch Score was determined from the worst weekly itch score for the month (4 weeks). Baseline is the worst weekly itch score in the 28 days prior to randomization (Day 1). Responders were defined as participants achieving \>=2-point reduction (improvement) from baseline in the Monthly Itch Score. Percentage of Responders achieving \>= 2-point Reduction from Baseline in the Monthly Itch Score at Week 24 was the third endpoint tested in the hierarchical analysis.

Outcome measures

Outcome measures
Measure	Part A: Linerixibat 40 Milligrams (mg) n=119 Participants Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part A: Placebo n=119 Participants Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).
Part A: Percentage of Responders Defined as Achieving More Than or Equal to (>=) 2-point Reduction From Baseline in the Monthly Itch Score at Week 24	68.0 Percentage of participants	64.0 Percentage of participants

SECONDARY outcome

Timeframe: At Week 24

Population: The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Percentage values were rounded to the nearest whole number.

Monthly Itch Score was assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The Monthly Itch Score was determined from the worst weekly itch score for the month (4 weeks). Baseline is the worst weekly itch score in the 28 days prior to randomization. Responders were defined as participants achieving \>=3-point reduction (improvement) from baseline in the Monthly Itch Score. Percentage of Responders achieving \>= 3-point Reduction from Baseline in the Monthly Itch Score at Week 24 was the fourth endpoint to be tested in the hierarchical analysis.

Outcome measures

Outcome measures
Measure	Part A: Linerixibat 40 Milligrams (mg) n=119 Participants Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part A: Placebo n=119 Participants Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).
Part A: Percentage of Responders Achieving >=3-point Reduction From Baseline in the Monthly Itch Score at Week 24	56.0 Percentage of participants	43.0 Percentage of participants

SECONDARY outcome

Timeframe: At Week 24

Population: The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Percentage values were rounded to the nearest whole number.

Monthly Itch Score was assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The Monthly Itch Score was determined from the worst weekly itch score for the month (4 weeks). Baseline is the worst weekly itch score in the 28 days prior to randomization. Responders were defined as participants achieving \>=4-point reduction (improvement) from baseline in the Monthly Itch Score. Percentage of Responders achieving \>= 4-point Reduction from Baseline in the Monthly Itch Score at Week 24 was the fifth endpoint to be tested in the hierarchical analysis.

Outcome measures

Outcome measures
Measure	Part A: Linerixibat 40 Milligrams (mg) n=119 Participants Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part A: Placebo n=119 Participants Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).
Part A: Percentage of Responders as Achieving a >=4-point Reduction From Baseline in the Monthly Itch Score at Week 24	41.0 Percentage of participants	29.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: ITT population set included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Number of Participants Analyzed (N) was the maximum number of participants analyzed for any domain, while Number analyzed (n) was the number of participants included in the model for each domain.

PBC-40 is a disease-specific health-related quality of life (HRQoL) questionnaire validated for use in participants with PBC. It consists of 40 questions, which are grouped into 6 domains with 3 to 11 questions per domain. Each question is scored from 1 (least impact) to 5 (greatest impact). For all questions, an answer of "Does/Did not apply" was scored 0. All questions within a domain are summed to obtain individual domain score. Domains were: Symptoms (7 questions) with score range 6 to 35, Itch (3 questions) with score range 0 to 15, Fatigue (11 questions) with score range 11 to 55 , Cognitive (6 questions) with score range 6 to 30 , Emotional (3 questions) with score range 3 to 15 and Social (10 questions) with score range 8 to 50 . Higher scores for individual domains represent poorer quality of life. Baseline is the last assessment prior to the first dose of randomized treatment (Day 1). Change from Baseline was calculated as Week 24 value minus Baseline value.

Outcome measures

Outcome measures
Measure	Part A: Linerixibat 40 Milligrams (mg) n=95 Participants Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part A: Placebo n=100 Participants Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).
Part A: Mean Change From Baseline in Primary Biliary Cholangitis-40 (PBC-40) Domain Scores at Week 24 Cognitive (score range: 6 to 30)	-0.71 Scores on a scale Interval -1.6 to 0.18	-1.47 Scores on a scale Interval -2.36 to -0.58
Part A: Mean Change From Baseline in Primary Biliary Cholangitis-40 (PBC-40) Domain Scores at Week 24 Emotional (score range: 3 to 15)	-1.07 Scores on a scale Interval -1.57 to -0.57	-1.34 Scores on a scale Interval -1.83 to -0.84
Part A: Mean Change From Baseline in Primary Biliary Cholangitis-40 (PBC-40) Domain Scores at Week 24 Fatigue (score range: 11 to 55)	-2.94 Scores on a scale Interval -4.63 to -1.26	-4.54 Scores on a scale Interval -6.21 to -2.86
Part A: Mean Change From Baseline in Primary Biliary Cholangitis-40 (PBC-40) Domain Scores at Week 24 Itch (score range: 0 to 15)	-3.47 Scores on a scale Interval -4.08 to -2.86	-2.89 Scores on a scale Interval -3.5 to -2.28
Part A: Mean Change From Baseline in Primary Biliary Cholangitis-40 (PBC-40) Domain Scores at Week 24 Social (score range: 8 to 50)	-2.57 Scores on a scale Interval -3.71 to -1.43	-2.42 Scores on a scale Interval -3.56 to -1.29
Part A: Mean Change From Baseline in Primary Biliary Cholangitis-40 (PBC-40) Domain Scores at Week 24 Symptoms (score range: 6 to 35)	0.54 Scores on a scale Interval -0.18 to 1.25	0.08 Scores on a scale Interval -0.62 to 0.79

SECONDARY outcome

Timeframe: Baseline and up to Week 24

The Patient's Global Impression of Severity (PGI-S) is a patient-reported outcome measure used to assess the severity of symptoms from the participant's perspective. The PGI-S asks participant to rate the severity of their itch in the past 7 days on a single item, using a scale ranging from 0 (absent) to 5 (very severe). Higher score indicates higher severity. Baseline is the last assessment prior to the first dose of randomized treatment for Part A (Day 1). Change from Baseline is defined as the post dose value minus baseline value. LS means and the corresponding 95% confidence intervals are reported by taking average of LS means of change from baseline in PGI-S obtained over 24 weeks using equal weighting for all time points, analyzed using Mixed Model Repeated Measures (MMRM) method.

Outcome measures

Outcome measures
Measure	Part A: Linerixibat 40 Milligrams (mg) n=114 Participants Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part A: Placebo n=111 Participants Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).
Part A: Mean Change From Baseline in Patient's Global Impression of Severity (PGI-S) Over 24 Weeks	-1.22 Scores on a scale Interval -1.36 to -1.07	-0.84 Scores on a scale Interval -0.99 to -0.7

SECONDARY outcome

Timeframe: Week 4 up to Week 24

Patient's Global Impression of Change (PGI-C) was assessed using a 7-level response scale, ranging from 1 (very much improved) to 7 (very much worse). Higher score indicates higher level of change. LS means and the corresponding 95% confidence intervals are reported by taking average of LS means of PGI-C obtained over 24 weeks using equal weighting for all timepoints, analyzed using Mixed Model Repeated Measures (MMRM) method.

Outcome measures

Outcome measures
Measure	Part A: Linerixibat 40 Milligrams (mg) n=117 Participants Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part A: Placebo n=116 Participants Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).
Part A: Patient's Global Impression of Change (PGI-C) Scores Over 24 Weeks	1.97 Scores on a scale Interval 1.74 to 2.2	2.46 Scores on a scale Interval 2.23 to 2.69

SECONDARY outcome

Timeframe: Baseline and Week 24

Blood samples were collected at indicated time points for evaluation of ALP. Change from Baseline in ALP at Week 24 was evaluated. Baseline was established using an average of two sets of laboratory values obtained at least 4 weeks apart within 56 days prior to randomization (Day 1). Change from Baseline was calculated as Week 24 value minus Baseline value.

Outcome measures

Outcome measures
Measure	Part A: Linerixibat 40 Milligrams (mg) n=102 Participants Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part A: Placebo n=107 Participants Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).
Part A: Mean Change From Baseline in Alkaline Phosphatase (ALP) at Week 24	10.61 International units per liter (IU/L) Interval -8.53 to 29.74	-8.03 International units per liter (IU/L) Interval -26.79 to 10.74

SECONDARY outcome

Timeframe: Baseline and Week 24

Blood samples were collected at indicated time points for evaluation of Bilirubin. Change from Baseline in total bilirubin at Week 24 was evaluated. Baseline was established using an average of two sets of laboratory values obtained at least 4 weeks apart within 56 days prior to randomization (Day 1). Change from Baseline was calculated as Week 24 value minus Baseline value.

Outcome measures

Outcome measures
Measure	Part A: Linerixibat 40 Milligrams (mg) n=102 Participants Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part A: Placebo n=107 Participants Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).
Part A: Mean Change From Baseline in Bilirubin at Week 24	1.77 Micromoles per Liter (mmol/L) Interval 0.84 to 2.71	-0.31 Micromoles per Liter (mmol/L) Interval -1.24 to 0.62

Adverse Events

Part A: Placebo

Serious events: 4 serious events

Other events: 54 other events

Deaths: 0 deaths

Part A: Linerixibat 40 Milligrams (mg)

Serious events: 14 serious events

Other events: 96 other events

Deaths: 0 deaths

Part B: Placebo in Part A and Part B

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part B: Placebo in Part A and Linerixibat 40 mg in Part B

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Part B: Linerixibat 40 mg in Part A and Placebo in Part B

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B: Linerixibat 40 mg in Part A and Part B

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Placebo n=118 participants at risk Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).	Part A: Linerixibat 40 Milligrams (mg) n=119 participants at risk Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part B: Placebo in Part A and Part B n=53 participants at risk Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, continued to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.	Part B: Placebo in Part A and Linerixibat 40 mg in Part B n=52 participants at risk Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, switched to receive linerixibat 40 mg tablet orally twice a day (BID) (from Week 24 to Week 32) in Part B.	Part B: Linerixibat 40 mg in Part A and Placebo in Part B n=46 participants at risk Participants who were randomized to receive linerixibat 40 mg tablet orally BID (up to Week 24) in Part A, switched to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.	Part B: Linerixibat 40 mg in Part A and Part B n=45 participants at risk Participants who were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) (up to Week 24) in Part A, continued to receive linerixibat 40 mg twice a day (BID) (from Week 24 to Week 32) in Part B.
Blood and lymphatic system disorders Anaemia	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.84% 1/119 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Blood and lymphatic system disorders Haemorrhagic disorder	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.84% 1/119 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/119 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	2.2% 1/46 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Cardiac disorders Sinus arrest	0.85% 1/118 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/119 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Gastrointestinal disorders Ascites	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.84% 1/119 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.84% 1/119 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Gastrointestinal disorders Gastric mucosal lesion	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.84% 1/119 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Hepatobiliary disorders Cholecystitis	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.84% 1/119 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Infections and infestations Clostridium difficile colitis	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.84% 1/119 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Infections and infestations Diverticulitis	0.85% 1/118 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/119 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Investigations Blood pressure increased	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.84% 1/119 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Metabolism and nutrition disorders Diabetes mellitus	0.85% 1/118 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/119 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.84% 1/119 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.84% 1/119 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.84% 1/119 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Nervous system disorders Dizziness	0.85% 1/118 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/119 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.84% 1/119 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/119 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	2.2% 1/46 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Nervous system disorders Cerebral infarction	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.84% 1/119 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Nervous system disorders Cerebrovascular accident	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.84% 1/119 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Nervous system disorders Syncope	0.85% 1/118 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/119 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Reproductive system and breast disorders Intermenstrual bleeding	0.85% 1/118 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/119 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.

Other adverse events

Other adverse events
Measure	Part A: Placebo n=118 participants at risk Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).	Part A: Linerixibat 40 Milligrams (mg) n=119 participants at risk Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).	Part B: Placebo in Part A and Part B n=53 participants at risk Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, continued to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.	Part B: Placebo in Part A and Linerixibat 40 mg in Part B n=52 participants at risk Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, switched to receive linerixibat 40 mg tablet orally twice a day (BID) (from Week 24 to Week 32) in Part B.	Part B: Linerixibat 40 mg in Part A and Placebo in Part B n=46 participants at risk Participants who were randomized to receive linerixibat 40 mg tablet orally BID (up to Week 24) in Part A, switched to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.	Part B: Linerixibat 40 mg in Part A and Part B n=45 participants at risk Participants who were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) (up to Week 24) in Part A, continued to receive linerixibat 40 mg twice a day (BID) (from Week 24 to Week 32) in Part B.
Blood and lymphatic system disorders Anaemia	5.9% 7/118 • Number of events 8 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	1.7% 2/119 • Number of events 2 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Gastrointestinal disorders Abdominal distension	5.1% 6/118 • Number of events 6 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	6.7% 8/119 • Number of events 10 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Gastrointestinal disorders Abdominal pain	3.4% 4/118 • Number of events 4 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	18.5% 22/119 • Number of events 27 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Gastrointestinal disorders Abdominal pain upper	4.2% 5/118 • Number of events 6 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	6.7% 8/119 • Number of events 14 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Gastrointestinal disorders Constipation	9.3% 11/118 • Number of events 11 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	7.6% 9/119 • Number of events 9 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Gastrointestinal disorders Diarrhoea	17.8% 21/118 • Number of events 28 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	60.5% 72/119 • Number of events 112 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	5.7% 3/53 • Number of events 3 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	26.9% 14/52 • Number of events 18 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	13.3% 6/45 • Number of events 12 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Gastrointestinal disorders Dyspepsia	0.85% 1/118 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	7.6% 9/119 • Number of events 9 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Gastrointestinal disorders Gastrooesophageal reflux disease	4.2% 5/118 • Number of events 9 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	6.7% 8/119 • Number of events 13 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Gastrointestinal disorders Nausea	9.3% 11/118 • Number of events 13 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	10.1% 12/119 • Number of events 17 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
General disorders Pyrexia	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/119 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	3.8% 2/53 • Number of events 2 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	5.8% 3/52 • Number of events 3 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	2.2% 1/45 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Infections and infestations COVID-19	2.5% 3/118 • Number of events 3 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	6.7% 8/119 • Number of events 9 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Investigations Alanine aminotransferase increased	3.4% 4/118 • Number of events 4 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	9.2% 11/119 • Number of events 12 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Investigations Aspartate aminotransferase increased	0.85% 1/118 • Number of events 1 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	8.4% 10/119 • Number of events 11 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Musculoskeletal and connective tissue disorders Arthralgia	5.1% 6/118 • Number of events 9 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	5.9% 7/119 • Number of events 8 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Nervous system disorders Dizziness	2.5% 3/118 • Number of events 4 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	5.9% 7/119 • Number of events 7 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Nervous system disorders Headache	3.4% 4/118 • Number of events 5 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	8.4% 10/119 • Number of events 10 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/46 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.
Skin and subcutaneous tissue disorders Cholestatic pruritus	0.00% 0/118 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/119 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/53 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/52 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	6.5% 3/46 • Number of events 3 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.	0.00% 0/45 • SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call. All randomized participants from ITT population (N=238) were included in Part A. One participant in Part A was not included in Safety population (N=237) and 15 participants from ITT Population (N=211) in Part B were not included in Safety population (N=196) as they did not receive study intervention.

Additional Information

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