Trial Outcomes & Findings for Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis (NCT NCT01437787)

Last Updated: 2026-08-11

Results Overview

Spleen volume was determined by magnetic resonance imaging (MRI) (or computed tomography scan in participants with contraindications for MRI) at baseline and at the end of cycle 6 with a confirmatory scan approximately 4 weeks after the end of Cycle 6. The MRI or CT imaging results reviewed in a blinded manner by an Independent Review Committee (IRC). Analysis was performed on intent-to-treat (ITT) population defined as all randomized participants who signed informed consent form (ICF).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

289 participants

Primary outcome timeframe

Baseline, Week 24

Results posted on

2026-08-11

Participant Flow

The study was conducted at 101 sites in 25 countries. A total of 351 participants were screened between 22 December 2011 and 24 August 2012.

Of 351 screened participants, 62 were screen failures and 289 were randomized.

Participant milestones

Participant milestones
Measure	Placebo Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.	SAR302503 400 mg SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).	SAR302503 500 mg SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).	Placebo Then SAR302503 400 mg At the end of cycle 6, participants were crossed-over to SAR302503 400 mg until disease progression or unacceptable toxicity.	Placebo Then SAR302503 500 mg At the end of cycle 6, participants were crossed-over to SAR302503 500 mg until disease progression or unacceptable toxicity.
Randomization until end of Cycle 6 STARTED	96	96	97	0	0
Randomization until end of Cycle 6 Treated	95	96	97	0	0
Randomization until end of Cycle 6 COMPLETED	61	0	0	0	0
Randomization until end of Cycle 6 NOT COMPLETED	35	96	97	0	0
Crossover After Cycle 6 STARTED	0	0	0	35	36
Crossover After Cycle 6 COMPLETED	0	0	0	0	0
Crossover After Cycle 6 NOT COMPLETED	0	0	0	35	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.	SAR302503 400 mg SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).	SAR302503 500 mg SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).
Randomization until end of Cycle 6 Withdrawal by participant	0	0	3
Randomization until end of Cycle 6 Disease progression	4	6	3
Randomization until end of Cycle 6 Randomized, but not treated	1	0	0
Randomization until end of Cycle 6 Poor compliance	0	1	1
Randomization until end of Cycle 6 Adverse Event	8	26	35
Randomization until end of Cycle 6 Other than specified	12	10	7
Randomization until end of Cycle 6 Participant request	0	2	3
Randomization until end of Cycle 6 Study termination by sponsor	0	51	45
Randomization until end of Cycle 6 Early crossover	10	0	0

Baseline Characteristics

Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=96 Participants Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.	SAR302503 400 mg n=96 Participants SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).	SAR302503 500 mg n=97 Participants SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).	Total n=289 Participants Total of all reporting groups
Age, Continuous	64.9 years STANDARD_DEVIATION 9.5 • n=54 Participants	62.9 years STANDARD_DEVIATION 9.6 • n=54 Participants	64.7 years STANDARD_DEVIATION 9.3 • n=27 Participants	64.2 years STANDARD_DEVIATION 9.5 • n=26 Participants
Sex: Female, Male Female	41 Participants n=54 Participants	42 Participants n=54 Participants	36 Participants n=27 Participants	119 Participants n=26 Participants
Sex: Female, Male Male	55 Participants n=54 Participants	54 Participants n=54 Participants	61 Participants n=27 Participants	170 Participants n=26 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants.

Outcome measures

Outcome measures
Measure	SAR302503 500 mg n=97 Participants SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).	Placebo n=96 Participants Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.	SAR302503 400 mg n=96 Participants SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).
Response Rate (RR): Percentage of Participants Who Had a >=35% Reduction From Baseline in Volume of Spleen Size at The End Cycle 6	40.2 percentage of participants 95% Confidence Interval 30.4 • Interval 30.4 to 50.0	1 percentage of participants 95% Confidence Interval 0 • Interval 0.0 to 3.1	36.5 percentage of participants 95% Confidence Interval 26.8 • Interval 26.8 to 46.1

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All treated participants with available data at baseline and the end of cycle 6.

Total symptom score is the averaged value of the daily scores for each of 6 key Myelofibrosis (MF) associated Symptom items (night sweats, pruritus, abdominal discomfort, early satiety \[filling up quickly when you eat\], pain under ribs on left side, and bone or muscle pain), each item measured on a scale from 0 (absent) to 10 (worst imaginable). A higher score indicates worse symptoms. Analysis was performed on ITT population. Number of participants analysed= participants with available data at end of cycle 6.

Outcome measures

Outcome measures
Measure	SAR302503 500 mg n=91 Participants SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).	Placebo n=85 Participants Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.	SAR302503 400 mg n=91 Participants SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).
Symptom Response Rate (SRR): Percentage of Participants With >=50% Reduction From Baseline in the Total Symptom Score at End of Cycle 6	34.1 percentage of participants 95% Confidence Interval 24.3 • Interval 24.3 to 43.8	7.1 percentage of participants 95% Confidence Interval 1.6 • Interval 1.6 to 12.5	36.3 percentage of participants 95% Confidence Interval 26.4 • Interval 26.4 to 46.1

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants

Spleen volume was determined by magnetic resonance imaging (MRI) (or computed tomography scan in subjects with contraindications for MRI) at baseline and at the end of cycle 6 with a confirmatory scan approximately 4 weeks after the end of Cycle 6. Analysis was performed on ITT population.

Outcome measures

Outcome measures
Measure	SAR302503 500 mg n=97 Participants SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).	Placebo n=96 Participants Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.	SAR302503 400 mg n=96 Participants SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).
Percentage of Participants Who Had >=25% Reduction From Baseline in Volume of Spleen Size at End of Cycle 6	51.5 percentage of participants 95% Confidence Interval 41.6 • Interval 41.6 to 61.5	2.1 percentage of participants 95% Confidence Interval 0 • Interval 0.0 to 4.9	49 percentage of participants 95% Confidence Interval 39 • Interval 39.0 to 59.0

Adverse Events

Placebo

Serious events: 22 serious events

Other events: 76 other events

Deaths: 6 deaths

SAR302503 400 mg

Serious events: 37 serious events

Other events: 96 other events

Deaths: 5 deaths

SAR302503 500 mg

Serious events: 43 serious events

Other events: 94 other events

Deaths: 6 deaths

SAR302503 400 mg After Cross-over

Serious events: 13 serious events

Other events: 33 other events

Deaths: 0 deaths

SAR302503 500 mg After Cross-over

Serious events: 13 serious events

Other events: 36 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=95 participants at risk Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.	SAR302503 400 mg n=96 participants at risk SAR302503 400 mg (from first dose after initial randomization to the end of study, median duration of exposure= 62.1 weeks).	SAR302503 500 mg n=97 participants at risk SAR302503 500 mg (from first dose after intial randomization to the end of study, median duration of exposure= 59.7 weeks).	SAR302503 400 mg After Cross-over n=35 participants at risk SAR302503 400 mg (from first dose after re-randomization to the end of study, median duration of exposure= 43.9 weeks).	SAR302503 500 mg After Cross-over n=36 participants at risk SAR302503 500 mg (from first dose after re-randomization to the end of study, median duration of exposure= 44.2 weeks).
Investigations Occult Blood	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Blood and lymphatic system disorders Anaemia	1.1% 1/95 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	4.2% 4/96 • Number of events 5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.2% 5/97 • Number of events 23 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.6% 3/35 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.6% 2/36 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/96 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Blood and lymphatic system disorders Haemorrhagic Anaemia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Blood and lymphatic system disorders Leukocytosis	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Blood and lymphatic system disorders Neutropenia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Blood and lymphatic system disorders Splenic Haemorrhage	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Blood and lymphatic system disorders Splenic Infarction	2.1% 2/95 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Cardiac disorders Acute Coronary Syndrome	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Cardiac disorders Acute Left Ventricular Failure	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Cardiac disorders Acute Myocardial Infarction	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Cardiac disorders Angina Unstable	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Cardiac disorders Atrial Fibrillation	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/96 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Cardiac disorders Cardiac Arrest	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Cardiac disorders Cardiac Disorder	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Cardiac disorders Cardiac Failure	3.2% 3/95 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.2% 5/96 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	3.1% 3/97 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Cardiac disorders Cardio-Respiratory Arrest	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Cardiac disorders Cardiogenic Shock	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Cardiac disorders Left Ventricular Dysfunction	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Cardiac disorders Myocardial Ischaemia	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Cardiac disorders Right Ventricular Failure	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Endocrine disorders Adrenal Haemorrhage	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Eye disorders Amaurosis Fugax	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Eye disorders Periorbital Oedema	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Eye disorders Vitreous Haemorrhage	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Abdominal Pain	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Abdominal Wall Haematoma	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Ascites	3.2% 3/95 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Colitis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Diarrhoea	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Gastritis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Gastrointestinal Polyp Haemorrhage	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Haematemesis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Ileus Paralytic	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Nausea	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Pancreatitis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Small Intestinal Perforation	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Umbilical Hernia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Volvulus	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Vomiting	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.6% 2/36 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
General disorders and administration site conditions Disease Progression	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/96 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
General disorders and administration site conditions Localised Oedema	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
General disorders and administration site conditions Multi-Organ Failure	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
General disorders and administration site conditions Pyrexia	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Hepatobiliary disorders Cholecystitis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Hepatobiliary disorders Cholelithiasis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Hepatobiliary disorders Hydrocholecystis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Abscess Limb	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Abscess Oral	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Anal Abscess	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Appendicitis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Bacterial Pyelonephritis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Bronchitis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Bronchopneumonia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Cystitis Escherichia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Enterocolitis Infectious	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Gastroenteritis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Implant Site Infection	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Infective Exacerbation Of Chronic Obstructive Airways Disease	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Klebsiella Sepsis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Lower Respiratory Tract Infection	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Lower Respiratory Tract Infection Viral	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Lung Abscess	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Lung Infection	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Neutropenic Sepsis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Peritonitis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Pneumonia	2.1% 2/95 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	4.2% 4/96 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	3.1% 3/97 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Sepsis	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/96 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Septic Shock	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Staphylococcal Sepsis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Tracheobronchitis	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Injury, poisoning and procedural complications Adrenal Haematoma	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Injury, poisoning and procedural complications Contusion	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Injury, poisoning and procedural complications Femur Fracture	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Injury, poisoning and procedural complications Muscle Rupture	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Injury, poisoning and procedural complications Procedural Intestinal Perforation	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Injury, poisoning and procedural complications Transfusion-Related Acute Lung Injury	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Investigations Alanine Aminotransferase Increased	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Investigations Amylase Increased	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Investigations Aspartate Aminotransferase Increased	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Investigations Lipase Increased	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Investigations Liver Function Test Abnormal	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Metabolism and nutrition disorders Cachexia	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Metabolism and nutrition disorders Hyperkalaemia	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Musculoskeletal and connective tissue disorders Pathological Fracture	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Leukaemia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukaemia	2.1% 2/95 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/96 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Of Colon	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Lymphocytic Leukaemia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Adenocarcinoma	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Nervous system disorders Cerebrovascular Accident	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Nervous system disorders Convulsion	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Nervous system disorders Dizziness	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Nervous system disorders Encephalopathy	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Nervous system disorders Haemorrhage Intracranial	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Nervous system disorders Haemorrhagic Stroke	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Nervous system disorders Headache	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Nervous system disorders Hypoglycaemic Coma	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Nervous system disorders Wernicke's Encephalopathy	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.6% 2/36 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Renal and urinary disorders Renal Colic	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Renal and urinary disorders Renal Cyst	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Renal and urinary disorders Renal Failure Acute	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Renal and urinary disorders Renal Failure Chronic	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Renal and urinary disorders Urinary Retention	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Reproductive system and breast disorders Vaginal Haemorrhage	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Lung Disorder	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Vascular disorders Aortic Stenosis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Vascular disorders Haematoma	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Vascular disorders Peripheral Artery Thrombosis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Vascular disorders Shock Haemorrhagic	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.

Other adverse events

Other adverse events
Measure	Placebo n=95 participants at risk Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.	SAR302503 400 mg n=96 participants at risk SAR302503 400 mg (from first dose after initial randomization to the end of study, median duration of exposure= 62.1 weeks).	SAR302503 500 mg n=97 participants at risk SAR302503 500 mg (from first dose after intial randomization to the end of study, median duration of exposure= 59.7 weeks).	SAR302503 400 mg After Cross-over n=35 participants at risk SAR302503 400 mg (from first dose after re-randomization to the end of study, median duration of exposure= 43.9 weeks).	SAR302503 500 mg After Cross-over n=36 participants at risk SAR302503 500 mg (from first dose after re-randomization to the end of study, median duration of exposure= 44.2 weeks).
Blood and lymphatic system disorders Anaemia	13.7% 13/95 • Number of events 15 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	52.1% 50/96 • Number of events 79 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	44.3% 43/97 • Number of events 77 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	60.0% 21/35 • Number of events 34 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	52.8% 19/36 • Number of events 32 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Blood and lymphatic system disorders Leukopenia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	3.1% 3/97 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.7% 2/35 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Blood and lymphatic system disorders Neutropenia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/96 • Number of events 10 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	12.4% 12/97 • Number of events 17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.6% 3/35 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.3% 3/36 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Blood and lymphatic system disorders Thrombocytopenia	8.4% 8/95 • Number of events 9 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	15.6% 15/96 • Number of events 22 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	20.6% 20/97 • Number of events 28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	22.9% 8/35 • Number of events 9 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	33.3% 12/36 • Number of events 13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Ear and labyrinth disorders Vertigo	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/96 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.7% 2/35 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Abdominal Discomfort	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/96 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	3.1% 3/97 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.6% 2/36 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Abdominal Distension	2.1% 2/95 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.2% 5/96 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/97 • Number of events 7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Abdominal Pain	15.8% 15/95 • Number of events 17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	15.6% 15/96 • Number of events 23 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	14.4% 14/97 • Number of events 19 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	11.4% 4/35 • Number of events 5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	16.7% 6/36 • Number of events 7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Abdominal Pain Upper	5.3% 5/95 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	10.4% 10/96 • Number of events 12 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.2% 5/97 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.7% 2/35 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	11.1% 4/36 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Constipation	7.4% 7/95 • Number of events 7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	12.5% 12/96 • Number of events 13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	19.6% 19/97 • Number of events 23 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	20.0% 7/35 • Number of events 8 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.3% 3/36 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Diarrhoea	15.8% 15/95 • Number of events 19 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	69.8% 67/96 • Number of events 106 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	58.8% 57/97 • Number of events 87 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	28.6% 10/35 • Number of events 15 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	38.9% 14/36 • Number of events 18 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Dyspepsia	2.1% 2/95 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	7.3% 7/96 • Number of events 9 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/97 • Number of events 7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.7% 2/35 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Flatulence	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	3.1% 3/96 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.6% 2/36 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Nausea	15.8% 15/95 • Number of events 15 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	66.7% 64/96 • Number of events 89 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	52.6% 51/97 • Number of events 62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	57.1% 20/35 • Number of events 26 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	44.4% 16/36 • Number of events 30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Gastrointestinal disorders Vomiting	5.3% 5/95 • Number of events 5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	45.8% 44/96 • Number of events 83 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	54.6% 53/97 • Number of events 107 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	37.1% 13/35 • Number of events 22 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	38.9% 14/36 • Number of events 26 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
General disorders and administration site conditions Asthenia	6.3% 6/95 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	13.5% 13/96 • Number of events 19 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	16.5% 16/97 • Number of events 19 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.6% 3/35 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	19.4% 7/36 • Number of events 9 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
General disorders and administration site conditions Fatigue	9.5% 9/95 • Number of events 9 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	25.0% 24/96 • Number of events 28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	14.4% 14/97 • Number of events 22 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	20.0% 7/35 • Number of events 10 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	13.9% 5/36 • Number of events 7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
General disorders and administration site conditions Local Swelling	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.2% 5/96 • Number of events 5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
General disorders and administration site conditions Oedema Peripheral	8.4% 8/95 • Number of events 8 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	13.5% 13/96 • Number of events 14 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	9.3% 9/97 • Number of events 10 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.6% 3/35 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.6% 2/36 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
General disorders and administration site conditions Pain	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	3.1% 3/96 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.6% 2/36 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
General disorders and administration site conditions Pyrexia	2.1% 2/95 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	7.3% 7/96 • Number of events 9 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/97 • Number of events 10 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.7% 2/35 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.3% 3/36 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Bronchitis	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	4.2% 4/96 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	3.1% 3/97 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	11.4% 4/35 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.6% 2/36 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Conjunctivitis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.6% 3/35 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Gastroenteritis	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.2% 5/96 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Nasopharyngitis	3.2% 3/95 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.2% 5/96 • Number of events 7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/97 • Number of events 7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Tooth Abscess	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.6% 2/36 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Upper Respiratory Tract Infection	4.2% 4/95 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.3% 8/96 • Number of events 10 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/97 • Number of events 7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	14.3% 5/35 • Number of events 5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Infections and infestations Urinary Tract Infection	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	9.4% 9/96 • Number of events 14 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	10.3% 10/97 • Number of events 13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.6% 2/36 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Injury, poisoning and procedural complications Contusion	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.2% 5/96 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Investigations Alanine Aminotransferase Increased	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	12.5% 12/96 • Number of events 16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	7.2% 7/97 • Number of events 7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	11.1% 4/36 • Number of events 5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Investigations Aspartate Aminotransferase Increased	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/96 • Number of events 7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.2% 8/97 • Number of events 9 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Investigations Blood Alkaline Phosphatase Increased	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/96 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.6% 2/36 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Investigations Blood Creatinine Increased	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	11.5% 11/96 • Number of events 12 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	17.5% 17/97 • Number of events 26 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.7% 2/35 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	11.1% 4/36 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Investigations Lipase Increased	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.3% 8/96 • Number of events 8 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	7.2% 7/97 • Number of events 10 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.6% 2/36 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Investigations Weight Decreased	5.3% 5/95 • Number of events 5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.2% 5/96 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	12.4% 12/97 • Number of events 12 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	17.1% 6/35 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.3% 3/36 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Investigations Weight Increased	4.2% 4/95 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	12.5% 12/96 • Number of events 12 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.2% 8/97 • Number of events 8 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.3% 3/36 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Metabolism and nutrition disorders Decreased Appetite	3.2% 3/95 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/96 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	9.3% 9/97 • Number of events 10 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.7% 2/35 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	11.1% 4/36 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/96 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Metabolism and nutrition disorders Hyperkalaemia	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.2% 5/96 • Number of events 5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	9.3% 9/97 • Number of events 14 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Metabolism and nutrition disorders Hyperuricaemia	4.2% 4/95 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	9.4% 9/96 • Number of events 11 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	3.1% 3/97 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Metabolism and nutrition disorders Hypocalcaemia	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	4.2% 4/96 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	3.1% 3/97 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.6% 2/36 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Musculoskeletal and connective tissue disorders Arthralgia	6.3% 6/95 • Number of events 7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	7.3% 7/96 • Number of events 8 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.6% 3/35 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Musculoskeletal and connective tissue disorders Back Pain	2.1% 2/95 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	3.1% 3/96 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	3.1% 3/97 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.3% 3/36 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Musculoskeletal and connective tissue disorders Bone Pain	2.1% 2/95 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	13.5% 13/96 • Number of events 17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.2% 8/97 • Number of events 13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Musculoskeletal and connective tissue disorders Muscle Spasms	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	15.6% 15/96 • Number of events 21 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.2% 8/97 • Number of events 11 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.7% 2/35 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.3% 3/36 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Musculoskeletal and connective tissue disorders Pain In Extremity	4.2% 4/95 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	12.5% 12/96 • Number of events 13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	3.1% 3/97 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Nervous system disorders Dizziness	3.2% 3/95 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	12.5% 12/96 • Number of events 16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	10.3% 10/97 • Number of events 11 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.7% 2/35 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Nervous system disorders Headache	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	13.5% 13/96 • Number of events 13 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/97 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Nervous system disorders Lethargy	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/96 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.6% 2/36 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Nervous system disorders Paraesthesia	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/96 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	3.1% 3/97 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.6% 2/36 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Psychiatric disorders Insomnia	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.2% 5/96 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Renal and urinary disorders Dysuria	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/96 • Number of events 7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/97 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.7% 2/35 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Cough	6.3% 6/95 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	14.6% 14/96 • Number of events 17 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	14.4% 14/97 • Number of events 14 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.6% 3/35 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.3% 3/36 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.3% 6/95 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	11.5% 11/96 • Number of events 12 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	13.4% 13/97 • Number of events 16 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	11.4% 4/35 • Number of events 5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	11.1% 4/36 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.2% 5/96 • Number of events 5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.1% 2/97 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.3% 6/95 • Number of events 8 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	7.3% 7/96 • Number of events 9 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	4.1% 4/97 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.7% 2/35 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.2% 5/96 • Number of events 5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	4.1% 4/97 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	4.2% 4/96 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	1.0% 1/97 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.7% 2/35 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Skin and subcutaneous tissue disorders Dry Skin	2.1% 2/95 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/96 • Number of events 7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.2% 5/97 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/35 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Skin and subcutaneous tissue disorders Night Sweats	2.1% 2/95 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/96 • Number of events 7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	4.1% 4/97 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Skin and subcutaneous tissue disorders Pruritus	2.1% 2/95 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/96 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	7.2% 7/97 • Number of events 8 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	0.00% 0/36 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Skin and subcutaneous tissue disorders Pruritus Generalised	6.3% 6/95 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/96 • Number of events 6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	3.1% 3/97 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.7% 2/35 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Skin and subcutaneous tissue disorders Rash	0.00% 0/95 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	4.2% 4/96 • Number of events 4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	5.2% 5/97 • Number of events 5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Social circumstances Blood Product Transfusion Dependent	2.1% 2/95 • Number of events 2 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	10.4% 10/96 • Number of events 10 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	12.4% 12/97 • Number of events 12 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	8.6% 3/35 • Number of events 3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
Vascular disorders Hypertension	1.1% 1/95 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	4.2% 4/96 • Number of events 5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	6.2% 6/97 • Number of events 7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.9% 1/35 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.	2.8% 1/36 • Number of events 1 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product. Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER