Trial Outcomes & Findings for Efficacy and Safety Trial of Verubecestat (MK-8931) in Participants With Prodromal Alzheimer's Disease (MK-8931-019) (NCT NCT01953601)

NCT ID: NCT01953601

Last Updated: 2019-05-17

Results Overview

LSM change from baseline at week 104 was assessed for CDR-SB score, a clinical rating of global cognitive function, comprised of 6 domains: memory; orientation; judgment and problem solving; community affairs; home and hobbies; and personal care. For each domain, the degree of impairment is assessed by a semi-structured interview of the participant as well as the participant's caregiver. For each domain, potential scores range from 0 (no impairment) to 3 (severe impairment). Individual domain scores are summed to a total CDR-SB score (range: 0-18). Higher scores indicate more severe cognitive impairment. Further, increases in cognitive impairment would be reflected by increases in CDR-SB score.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1454 participants

Primary outcome timeframe

Baseline and Week 104 in Part 1

Results posted on

2019-05-17

Participant Flow

N=1454 participants with prodromal Alzheimer's Disease (AD) were randomized, with N=1451 receiving study treatment.

This trial was conducted in 2 parts: a Base Study (Part 1), followed by an Extension Study (Part 2). Participants completing Part 1 had the option to continue to Part 2.

Participant milestones

Participant milestones
Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Part 1 (Base Study) STARTED	485	484	485
Part 1 (Base Study) Treated	483	484	484
Part 1 (Base Study) COMPLETED	234	231	239
Part 1 (Base Study) NOT COMPLETED	251	253	246
Part 2 (Extension Study) STARTED	198	191	204
Part 2 (Extension Study) Treated	197	191	204
Part 2 (Extension Study) COMPLETED	0	0	0
Part 2 (Extension Study) NOT COMPLETED	198	191	204

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Part 1 (Base Study) Adverse Event	24	37	15
Part 1 (Base Study) Death	2	0	3
Part 1 (Base Study) Lack of Efficacy	3	1	4
Part 1 (Base Study) Lost to Follow-up	1	3	6
Part 1 (Base Study) Non-compliance with study drug	0	3	1
Part 1 (Base Study) Physician Decision	3	7	4
Part 1 (Base Study) Screen failure	1	0	1
Part 1 (Base Study) Site discontinued study participation	2	0	0
Part 1 (Base Study) Study terminated by sponsor	174	169	179
Part 1 (Base Study) Discontinued due to caregiver withdrawal	7	8	10
Part 1 (Base Study) Subject moved	2	2	1
Part 1 (Base Study) Withdrawal by Subject	32	23	22
Part 2 (Extension Study) Adverse Event	1	1	10
Part 2 (Extension Study) Death	0	3	0
Part 2 (Extension Study) Lack of Efficacy	2	0	0
Part 2 (Extension Study) Lost to Follow-up	2	1	1
Part 2 (Extension Study) Physician Decision	2	0	2
Part 2 (Extension Study) Site discontinued study participation	0	1	1
Part 2 (Extension Study) Study terminated by sponsor	185	178	187
Part 2 (Extension Study) Discontinued due to caregiver withdrawal	1	3	0
Part 2 (Extension Study) Subject moved	0	0	1
Part 2 (Extension Study) Withdrawal by Subject	5	4	2

Baseline Characteristics

Includes all randomized participants receiving ≥1 dose of study treatment.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline and Week 104 in Part 1

Population: Includes all participants receiving ≥1 dose of study treatment in Part 1 who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose CDR-SB observation; and 2) tested positive for cortical amyloid load by PET.

Outcome measures

Outcome measures
Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) n=465 Participants \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) n=458 Participants \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) n=469 Participants \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Part 1 (Base Study). Least Squares Mean (LSM) Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 104	1.6 Score on a Scale Interval 1.4 to 1.9	2.0 Score on a Scale Interval 1.8 to 2.3	1.6 Score on a Scale Interval 1.3 to 1.8

PRIMARY outcome

Timeframe: Baseline and Week 130 (i.e., Week 26 of Part 2)

Population: All randomized participants continuing to Part 2, with: 1) both a pre-dose baseline and ≥1 within-analysis-window, post-dose CDR-SB observation; 2) a positive test for cortical amyloid load by PET; and 3) a CDR-SB observation at week 130.

Mean change from baseline at week 130 was assessed for CDR-SB score, a clinical rating of global cognitive function, comprised of 6 domains: memory; orientation; judgment and problem solving; community affairs; home and hobbies; and personal care. For each domain, the degree of impairment is assessed by a semi-structured interview of the participant as well as the participant's caregiver. For each domain, potential scores range from 0 (no impairment) to 3 (severe impairment). Individual domain scores are summed to a total CDR-SB score (range: 0-18). Higher scores indicate more severe cognitive impairment. Further, increases in cognitive impairment would be reflected by increases in CDR-SB score. Per protocol, baseline refers to the baseline measurement obtained in Part 1.

Outcome measures

Outcome measures
Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) n=120 Participants \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) n=113 Participants \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) n=124 Participants \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Part 2 (Extension Study). Mean Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 130	2.0 Score on a Scale Standard Deviation 2.5	1.9 Score on a Scale Standard Deviation 2.2	1.5 Score on a Scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: Up to Week 106 (up to 2 weeks following cessation of study treatment in Part 1)

Population: All randomized participants in Part 1, receiving ≥1 dose of study treatment.

The percentage of participants experiencing an AE in Part 1 was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.

Outcome measures

Outcome measures
Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) n=483 Participants \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) n=484 Participants \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) n=484 Participants \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Part 1 (Base Study). Percentage of Participants Who Experienced ≥1 Adverse Event (AE)	91.3 Percentage of Participants	92.1 Percentage of Participants	87.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to Week 104 in Part 1

Population: All randomized participants in Part 1, receiving ≥1 dose of study treatment.

The percentage of participants who discontinued from study drug due to an AE in Part 1 was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.

Outcome measures

Outcome measures
Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) n=483 Participants \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) n=484 Participants \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) n=484 Participants \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Part 1 (Base Study). Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event (AE)	6.6 Percentage of Participants	10.1 Percentage of Participants	4.5 Percentage of Participants

PRIMARY outcome

Timeframe: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2)

Population: All randomized participants continuing to Part 2, receiving ≥1 dose of trial treatment in Part 2. For included participants, the data reflect AEs occurring in Part 2 only.

The percentage of participants experiencing an AE in Part 2 was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.

Outcome measures

Outcome measures
Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) n=197 Participants \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) n=191 Participants \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) n=204 Participants \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Part 2 (Extension Study). Percentage of Participants Who Experienced ≥1 Adverse Event (AE)	59.4 Percentage of Participants	55.5 Percentage of Participants	66.2 Percentage of Participants

PRIMARY outcome

Timeframe: From Week 104 (start of treatment in Part 2) up to Week 208 (i.e., up to Week 104 in Part 2)

Population: All randomized participants continuing to Part 2, receiving ≥1 dose of trial treatment in Part 2. For included participants, the data reflect discontinuations occurring in Part 2 only.

The percentage of participants who discontinued from study drug due to an AE in Part 2 was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.

Outcome measures

Outcome measures
Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) n=197 Participants \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) n=191 Participants \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) n=204 Participants \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Part 2 (Extension Study). Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event (AE)	1.0 Percentage of Participants	1.0 Percentage of Participants	3.4 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Week 104 in Part 1

Population: Includes all participants receiving ≥1 dose of study treatment in Part 1 who tested positive for cortical amyloid load by PET.

The event-rate per 100 participant-years for progression to a clinical diagnosis of probable AD dementia was calculated. Adjudication of a potential case was triggered if either: 1) in the investigator's own expert judgment, they think the participant may have progressed to dementia and/or 2) the participant's CDR-SB score is ≥2 points higher compared to baseline. Cases of progression to probable AD dementia confirmed by an external adjudication committee were counted as events in the analysis. The event-rate was calculated as the number of events divided by total follow-up time (participant-years) x 100; unit of measure is event-rate / 100 participant-years.

Outcome measures

Outcome measures
Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) n=480 Participants \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) n=481 Participants \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) n=481 Participants \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Part 1 (Base Study). Event-Rate Per 100 Participant Years for Progression to a Clinical Diagnosis of Probable AD Dementia	24.5 Event-Rate / 100 Participant-Years	25.5 Event-Rate / 100 Participant-Years	19.3 Event-Rate / 100 Participant-Years

SECONDARY outcome

Timeframe: Week 13 and Week 104 in Part 1

LSM difference between weeks 104 and 13 was estimated for CDR-SB score, a clinical rating of global cognitive function, comprised of 6 domains: memory; orientation; judgment / problem solving; community affairs; home / hobbies; and personal care. For each domain, degree of impairment is scored by a semi-structured interview of the participant and the participant's caregiver (domain score range: 0 \[no impairment\] to 3 \[severe impairment\]). Domain scores sum to a total CDR-SB score (range: 0-18); higher scores indicate more severe cognitive impairment. Further, increased cognitive impairment is reflected by higher CDR-SB scores; larger differences between week 104 and week 13 scores indicates accelerated AD progression.

Outcome measures

Outcome measures
Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) n=465 Participants \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) n=458 Participants \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) n=469 Participants \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Part 1 (Base Study). Estimated Least Squares Mean Difference Between the Last (Week 104) and First (Week 13) Post-dose CDR-SB Assessment	1.5 Score on a Scale Interval 1.3 to 1.7	1.8 Score on a Scale Interval 1.5 to 2.0	1.5 Score on a Scale Interval 1.3 to 1.7

SECONDARY outcome

Timeframe: Baseline and Week 104 in Part 1

Population: Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose CCS-3D observation; and 2) tested positive for cortical amyloid load by PET.

CCS-3D is composed of individual cognitive tests, grouped into 3 domains: 1) episodic memory; 2) executive function; and 3) attention/processing speed. For each cognitive test, a z-score (Z) is calculated at each time point \[Z = (observed value - study population mean at baseline) / study population standard deviation at baseline\]. These individual Zs are first combined into domain-specific Zs, and then into a composite Z, (i.e. CCS-3D). Theoretically, 99.9% of CCS-3D will be ± 3; more positive CCS-3D indicate greater cognitive impairment relative to the total study population at baseline. Further, negative changes in CCS-3D over time indicate improved cognition relative to the total study population at baseline.

Outcome measures

Outcome measures
Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) n=441 Participants \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) n=424 Participants \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) n=440 Participants \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Part 1 (Base Study). Least Squares Mean Change From Baseline in the 3-Domain Composite Cognition Score (CCS-3D) at Week 104	0.8 Z-score Interval 0.7 to 0.9	0.8 Z-score Interval 0.7 to 0.9	0.8 Z-score Interval 0.7 to 0.9

SECONDARY outcome

Timeframe: Baseline and Week 104 in Part 1

Population: Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose THV observation; and 2) tested positive for cortical amyloid load by PET.

Least squares mean percent change from baseline at week 104 was calculated for THV as measured by volumetric magnetic resonance imaging (vMRI). Negative percent changes from baseline indicate decreases in THV (i.e. increased hippocampal atrophy).

Outcome measures

Outcome measures
Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) n=168 Participants \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) n=181 Participants \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) n=191 Participants \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Part 1 (Base Study). Least Squares Mean Percent Change From Baseline in Total Hippocampal Volume (THV) at Week 104	-6.5 Percent Change Interval -6.9 to -6.2	-6.7 Percent Change Interval -7.1 to -6.3	-6.1 Percent Change Interval -6.5 to -5.7

SECONDARY outcome

Timeframe: Baseline and Week 104 in Part 1

Population: Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose SUVR observation; and 2) tested positive for cortical amyloid load by PET.

\[18F\]Flutemetamol PET SUVR measures brain cortical amyloid load. The PET tracer \[18F\]Flutemetamol was given intravenously (IV). After 90 minutes, participants were scanned for 20 minutes. Using the PET scan images, SUVRs, the ratio of tracer signal in a specific region compared to a reference region (RR; subcortical white matter) are calculated for brain regions of interest (ROIs). SUVRs from a selected set of brain regions are averaged to compute a composite SUVR. Higher composite SUVR values indicate increased amyloid load in selected brain regions, with negative changes in composite cortical SUVR over time indicating decreases in brain amyloid load.

Outcome measures

Outcome measures
Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) n=63 Participants \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) n=59 Participants \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) n=65 Participants \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Part 1 (Base Study). Least Squares Mean Change From Baseline in Composite Cortical Amyloid Standard Uptake Value Ratio (SUVR) Assessed With Amyloid Tracer [18F]Flutemetamol Using Positron Emission Tomography (PET) Imaging at Week 104	-0.03 Standard Uptake Value Ratio (SUVR) Interval -0.04 to -0.03	-0.04 Standard Uptake Value Ratio (SUVR) Interval -0.05 to -0.04	0.02 Standard Uptake Value Ratio (SUVR) Interval 0.02 to 0.03

SECONDARY outcome

Timeframe: Baseline and Week 104 in Part 1

Population: Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose ADCS-ADL MCI observation; and 2) tested positive for cortical amyloid load by PET.

Least squares mean change from baseline at week 104 was assessed for the ADCS-ADL MCI score. The ADCS-ADL MCI is an 18-item assessment of recent, observed performance of activities of daily living administered to participants' trial partners in an interview format. For the 18 items, scores range from 0 (no independence) to (depending on the item) either 2 (5 items), 3 (9 items), or 4 (4 items), with higher scores indicating greater independence in activity performance. Scores from individual items sum to a total ADCS-ADL score (range: 0-53). Lower scores indicate less independence in activity performance and, as a result, greater AD severity. Further, increases in AD severity over time would be reflected by decreases in ADCS-ADL score.

Outcome measures

Outcome measures
Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) n=469 Participants \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) n=462 Participants \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) n=472 Participants \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Part 1 (Base Study). Least Squares Mean Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment Version) (ADCS-ADL MCI) Score at Week 104	-5.2 Score on a Scale Interval -6.1 to -4.3	-5.8 Score on a Scale Interval -6.8 to -4.8	-4.1 Score on a Scale Interval -5.0 to -3.3

SECONDARY outcome

Timeframe: Baseline and Week 104 in Part 1

Population: Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose observation for CSF Total Tau concentration; and 2) tested positive for cortical amyloid load by PET. CSF Total Tau concentration was analyzed at select trial sites as a Part 1 substudy.

Mean percent change from baseline at week 104 was calculated for Total Tau concentration in CSF, a measure of brain tau pathology. Per protocol, CSF Total Tau concentration was analyzed as part of a substudy in Part 1, with testing occurring only at select trial sites.

Outcome measures

Outcome measures
Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) n=5 Participants \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) n=6 Participants \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) n=6 Participants \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Part 1 (Base Study). Mean Percent Change From Baseline in Cerebrospinal Fluid (CSF) Total Tau Concentration at Week 104	33.2 Percent Change Standard Deviation 44.3	42.8 Percent Change Standard Deviation 39.7	10.2 Percent Change Standard Deviation 27.9

Adverse Events

Arm A. Verubecestat 12 mg (Part 1)

Serious events: 124 serious events

Other events: 221 other events

Deaths: 3 deaths

Arm B. Verubecestat 40 mg (Part 1)

Serious events: 101 serious events

Other events: 223 other events

Deaths: 1 deaths

Arm C. Placebo (Part 1)

Serious events: 96 serious events

Other events: 202 other events

Deaths: 3 deaths

Arm A. Verubecestat 12 mg (Part 2)

Serious events: 10 serious events

Other events: 39 other events

Deaths: 0 deaths

Arm B. Verubecestat 40 mg (Part 2)

Serious events: 22 serious events

Other events: 31 other events

Deaths: 3 deaths

Arm C. Verubecestat 40 mg (Part 2)

Serious events: 24 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A. Verubecestat 12 mg (Part 1) n=483 participants at risk \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study).	Arm B. Verubecestat 40 mg (Part 1) n=484 participants at risk \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study).	Arm C. Placebo (Part 1) n=484 participants at risk \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study).	Arm A. Verubecestat 12 mg (Part 2) n=197 participants at risk \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 2) n=191 participants at risk \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Verubecestat 40 mg (Part 2) n=204 participants at risk \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Cardiac disorders Acute myocardial infarction	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Angina pectoris aggravated	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Angina unstable	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Aortic valve stenosis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Arrhythmia	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Atrial fibrillation	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Atrial fibrillation aggravated	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Atrial fibrillation with rapid ventricular response	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Atrial flutter	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Bradycardia	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Cardiac failure congestive	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Coronary artery disease	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Coronary artery disease aggravated	0.41% 2/483 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Myocardial infarction	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Non ST segment elevation myocardial infarction	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Paroxysmal supraventricular tachycardia	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Recurrent atrial fibrillation	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Sick sinus syndrome	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Sinus bradycardia	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Supraventricular tachycardia	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Ventricular bigeminy	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Congenital, familial and genetic disorders Bronchogenic cyst	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Ear and labyrinth disorders Benign paroxysmal positional vertigo	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Ear and labyrinth disorders Vertigo	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Eye disorders Cataract	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Eye disorders Cataract bilateral NOS	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Eye disorders Right cataract	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Abdominal pain	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Acute enterocolitis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Colitis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Colitis ischaemic	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Diarrhoea	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Diverticular perforation	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Duodenal ulcer	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Gastric ulcer	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Gastritis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Gastrointestinal upset	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Haematochezia	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Haemorrhoids aggravated	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Indirect inguinal hernia	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Intestinal obstruction	0.41% 2/483 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Large intestine polyp	0.41% 2/483 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Left inguinal hernia	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Left upper quadrant pain	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Rectal prolapse	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Reflux oesophagitis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Right inguinal hernia	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Tenderness epigastric	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Vomiting	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
General disorders Acute chest pain	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
General disorders Chest pain	0.62% 3/483 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
General disorders Chest pain aggravated	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
General disorders Chest pressure	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
General disorders Fever	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
General disorders Fever of unknown origin	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
General disorders Gait abnormal	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
General disorders Non-cardiac chest pain	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Hepatobiliary disorders Bile duct stone	0.41% 2/483 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Hepatobiliary disorders Biliary tract disorder	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Hepatobiliary disorders Cholangitis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Hepatobiliary disorders Cholecystitis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Hepatobiliary disorders Cholelithiasis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Acute appendicitis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Acute diverticulitis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Bacillus bacteraemia	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Bacterial parotitis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Bacterial sepsis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Cellulitis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Cellulitis of foot	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Cellulitis of hand	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Cellulitis of leg	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Diverticulitis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Influenza B virus infection	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Liver abscess	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Lobar pneumonia	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Lung infection	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Osteomyelitis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Osteomyelitis acute	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Pneumonia	0.41% 2/483 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.62% 3/484 • Number of events 4 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.51% 1/197 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Pneumonia bacterial	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Postoperative wound infection	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Prosthesis related infection	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Pseudomonas infection	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Pyelonephritis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Septic arthritis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Septic shock	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Spinal cord infection	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Urinary tract infection	0.62% 3/483 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Viral infection	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Viral syndrome	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Alcohol intoxication	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Arm fracture	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Bimalleolar fracture	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Bruise of head	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Chronic subdural haematoma	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Fall	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.62% 3/484 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Femoral neck fracture	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Femur fracture	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Finger injury	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Fracture of intertrochanteric section of femur, closed	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Fractured mandible	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Head injury	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Hip fracture	0.41% 2/483 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Humerus fracture	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Joint ligament rupture	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Lumbar spine compression fracture	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Near drowning	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Olecranon fracture	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Pain trauma activated	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Post procedural pain	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Postoperative haematoma	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Postoperative hypotension	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Radius fracture	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Rib fracture	0.41% 2/483 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Scapula fracture	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Subarachnoid bleeding	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Subdural haematoma (traumatic)	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Thoracic vertebral fracture T12	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Traffic accident	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Trochanteric femoral fracture	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Vertebral fracture	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Investigations Creatinine increased	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Investigations Faecal occult blood	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Investigations Prostatic specific antigen increased	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Metabolism and nutrition disorders Dehydration	0.41% 2/483 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Metabolism and nutrition disorders Hypokalaemia	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Metabolism and nutrition disorders Hyponatraemia	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Metabolism and nutrition disorders Hyponatraemia aggravated	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Cervical spondylosis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Costochondritis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Coxarthrosis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Herniated disc	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Herniated nucleus pulposus	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Hips osteoarthritis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Knee osteoarthritis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Lumbar disc herniation	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Myalgia	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Osteoarthritis aggravated	0.62% 3/483 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Rotator cuff tear	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Spinal stenosis NOS	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of prostate	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Atypical fibroxanthoma	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.7% 13/483 • Number of events 14 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	1.7% 8/484 • Number of events 10 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	1.2% 6/484 • Number of events 7 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	2.0% 4/197 • Number of events 4 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	1.0% 2/191 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	1.5% 3/204 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma in situ of breast ductal	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervical cancer	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colonic tubular adenoma	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular thyroid cancer	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric adenoma	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo melanoma	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip basal cell carcinoma	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.62% 3/483 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	1.0% 5/484 • Number of events 5 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma in situ	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nodular basal cell carcinoma	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreas cancer	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate carcinoma	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin carcinoma	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.62% 3/483 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.51% 1/197 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of head and neck	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	1.0% 5/483 • Number of events 6 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.62% 3/484 • Number of events 4 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	1.0% 5/484 • Number of events 5 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.51% 1/197 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin in situ	0.21% 1/483 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 4 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin well differentiated	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the nasal cavity	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Superficial basal cell carcinoma	0.62% 3/483 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.62% 3/484 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urothelial carcinoma	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Ataxia	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Cerebrovascular accident	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Cerebrovascular insufficiency	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Complex partial seizures	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Dementia	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Dementia aggravated	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Dizziness	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.51% 1/197 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Embolic stroke	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Epileptic seizure	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Felt faint	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Haemorrhagic stroke	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Headache	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Lightheadedness	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Neurocardiogenic syncope	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Nonconvulsive status epilepticus	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Presyncope	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Seizure	0.41% 2/483 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.51% 1/197 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Stroke	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Syncopal attack	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Syncope	1.0% 5/483 • Number of events 5 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Thalamic infarction	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Transient cerebral ischaemia	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Transient global amnesia	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Transient ischaemic attack	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.62% 3/484 • Number of events 4 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Tremor aggravated	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Unconsciousness	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Abnormal behaviour	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Acute mania	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Agitation	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Anxiety	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Confusion aggravated	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Delirium	0.62% 3/483 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Delusion	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Disorientation	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Major depression	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Mental status changes	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Panic attack	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Psychosis aggravated	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Psychotic disorder	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Psychotic episode	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Somatisation disorder	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Suicidal ideation	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Suicide attempt	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Unsuccessful suicide	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Renal and urinary disorders Acute kidney injury	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Renal and urinary disorders Calculus renal	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Renal and urinary disorders Calculus ureteric	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Renal and urinary disorders Haematuria	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Renal and urinary disorders Hydronephrosis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Renal and urinary disorders Kidney stone	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Renal and urinary disorders Renal failure acute	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Renal and urinary disorders Renal mass	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Renal and urinary disorders Stone urinary bladder	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Renal and urinary disorders Ureteral stricture	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Renal and urinary disorders Ureterolithiasis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Renal and urinary disorders Urolithiasis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Reproductive system and breast disorders Bartholin's cyst	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Reproductive system and breast disorders Benign prostatic hypertrophy	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Reproductive system and breast disorders Cystocele	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Reproductive system and breast disorders Urogenital prolapse	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease exacerbation	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Respiratory, thoracic and mediastinal disorders Collapse of lung	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Respiratory, thoracic and mediastinal disorders Pharyngeal haematoma	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.41% 2/484 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.41% 2/483 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Skin and subcutaneous tissue disorders Exanthem	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Skin and subcutaneous tissue disorders Urticarial rash	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Vascular disorders Aortic aneurysm	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Vascular disorders Arterial stenosis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Vascular disorders Deep vein thrombosis	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Vascular disorders Hypertensive episode	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Vascular disorders Intermittent claudication	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.21% 1/484 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Vascular disorders Peripheral obliterative arteriopathy	0.21% 1/483 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Cardiac disorders Right coronary artery stenosis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Diverticular disease	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Pancreatitis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Gastrointestinal disorders Pyloric ulcer perforation	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Immune system disorders Hypersensitivity reaction	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Bacterial prostatitis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.51% 1/197 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Gastroenteritis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Influenza A virus infection	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Nasopharyngitis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Concussion	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Investigations Troponin increased	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Musculoskeletal and connective tissue disorders Back muscle spasms	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Dysarthria	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Lacunar infarction	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Neurologic reaction	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Acute delirium	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Skin and subcutaneous tissue disorders Hives	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.49% 1/204 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Vascular disorders Aortic stenosis	0.00% 0/483 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/484 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.52% 1/191 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.

Other adverse events

Other adverse events
Measure	Arm A. Verubecestat 12 mg (Part 1) n=483 participants at risk \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study).	Arm B. Verubecestat 40 mg (Part 1) n=484 participants at risk \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study).	Arm C. Placebo (Part 1) n=484 participants at risk \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study).	Arm A. Verubecestat 12 mg (Part 2) n=197 participants at risk \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 2) n=191 participants at risk \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Verubecestat 40 mg (Part 2) n=204 participants at risk \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.
Gastrointestinal disorders Diarrhoea	5.8% 28/483 • Number of events 35 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	4.3% 21/484 • Number of events 22 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	7.4% 36/484 • Number of events 38 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	3.0% 6/197 • Number of events 7 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	1.0% 2/191 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	1.5% 3/204 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Cold	3.3% 16/483 • Number of events 20 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	5.2% 25/484 • Number of events 28 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	5.0% 24/484 • Number of events 34 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.51% 1/197 • Number of events 1 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	2.1% 4/191 • Number of events 4 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	1.5% 3/204 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Common cold syndrome	4.6% 22/483 • Number of events 33 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	6.6% 32/484 • Number of events 48 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	5.4% 26/484 • Number of events 38 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	4.6% 9/197 • Number of events 10 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	1.6% 3/191 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	1.5% 3/204 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Upper respiratory tract infection	6.4% 31/483 • Number of events 37 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	4.3% 21/484 • Number of events 24 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	6.4% 31/484 • Number of events 38 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	1.5% 3/197 • Number of events 4 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	3.1% 6/191 • Number of events 6 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	2.0% 4/204 • Number of events 4 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Infections and infestations Urinary tract infection	6.2% 30/483 • Number of events 37 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	5.4% 26/484 • Number of events 35 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	4.8% 23/484 • Number of events 30 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	1.5% 3/197 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	1.6% 3/191 • Number of events 4 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	3.9% 8/204 • Number of events 10 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Injury, poisoning and procedural complications Fall	8.7% 42/483 • Number of events 56 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	7.4% 36/484 • Number of events 48 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	6.8% 33/484 • Number of events 41 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	4.1% 8/197 • Number of events 8 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	3.1% 6/191 • Number of events 8 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	3.4% 7/204 • Number of events 10 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Investigations Weight decreased	5.6% 27/483 • Number of events 27 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	6.6% 32/484 • Number of events 32 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	2.1% 10/484 • Number of events 10 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	3.0% 6/197 • Number of events 6 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	3.9% 8/204 • Number of events 8 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Dizziness	7.7% 37/483 • Number of events 49 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	6.4% 31/484 • Number of events 36 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	5.2% 25/484 • Number of events 25 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	2.0% 4/197 • Number of events 4 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	3.1% 6/191 • Number of events 6 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	2.0% 4/204 • Number of events 4 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Nervous system disorders Headache	6.6% 32/483 • Number of events 36 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	5.4% 26/484 • Number of events 27 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	5.0% 24/484 • Number of events 28 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/197 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/204 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Depression	3.5% 17/483 • Number of events 17 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	5.8% 28/484 • Number of events 29 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	2.7% 13/484 • Number of events 15 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	1.5% 3/197 • Number of events 3 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.00% 0/191 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	0.98% 2/204 • Number of events 2 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.
Psychiatric disorders Suicidal ideation	6.4% 31/483 • Number of events 48 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	8.3% 40/484 • Number of events 50 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	5.2% 25/484 • Number of events 26 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	3.0% 6/197 • Number of events 6 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	2.6% 5/191 • Number of events 5 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.	2.5% 5/204 • Number of events 5 • [Part 1]: Up to Week 106 of Part 1 (up to 2 weeks following cessation of study treatment in Part 1); [Part 2]: From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2). \[Part 1\] Includes all randomized participants in Part 1 (Base Study) receiving ≥1 dose of study treatment. \[Part 2\] Includes all randomized participants continuing to Part 2 (Extension Study) receiving ≥1 dose of study treatment in Part 2. For Part 2-specific arms, only the AEs occurring during Part 2 are reported.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER

Measure	Arm A. Verubecestat 12 mg (Part 1); 12 mg (Part 2) n=485 Participants \[Part 1\] Verubecestat 12 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 12 mg once daily for an additional 260 weeks.	Arm B. Verubecestat 40 mg (Part 1); 40 mg (Part 2) n=484 Participants \[Part 1\] Verubecestat 40 mg once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Arm C. Placebo (Part 1); Verubecestat 40 mg (Part 2) n=485 Participants \[Part 1\] Placebo once daily for 104 weeks in Part 1 (Base Study). \[Part 2\] Participants completing Part 1 and continuing to Part 2 (Extension Study) receive verubecestat 40 mg once daily for an additional 260 weeks.	Total n=1454 Participants Total of all reporting groups
Age, Continuous	71.7 Years STANDARD_DEVIATION 7.1 • n=485 Participants	71.0 Years STANDARD_DEVIATION 7.4 • n=484 Participants	71.6 Years STANDARD_DEVIATION 7.1 • n=485 Participants	71.4 Years STANDARD_DEVIATION 7.2 • n=1454 Participants
Sex: Female, Male Female	229 Participants n=485 Participants	244 Participants n=484 Participants	213 Participants n=485 Participants	686 Participants n=1454 Participants
Sex: Female, Male Male	256 Participants n=485 Participants	240 Participants n=484 Participants	272 Participants n=485 Participants	768 Participants n=1454 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=485 Participants	29 Participants n=484 Participants	29 Participants n=485 Participants	86 Participants n=1454 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	441 Participants n=485 Participants	439 Participants n=484 Participants	441 Participants n=485 Participants	1321 Participants n=1454 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=485 Participants	16 Participants n=484 Participants	15 Participants n=485 Participants	47 Participants n=1454 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=485 Participants	0 Participants n=484 Participants	2 Participants n=485 Participants	2 Participants n=1454 Participants
Race (NIH/OMB) Asian	79 Participants n=485 Participants	85 Participants n=484 Participants	84 Participants n=485 Participants	248 Participants n=1454 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=485 Participants	0 Participants n=484 Participants	0 Participants n=485 Participants	0 Participants n=1454 Participants
Race (NIH/OMB) Black or African American	5 Participants n=485 Participants	3 Participants n=484 Participants	6 Participants n=485 Participants	14 Participants n=1454 Participants
Race (NIH/OMB) White	397 Participants n=485 Participants	392 Participants n=484 Participants	391 Participants n=485 Participants	1180 Participants n=1454 Participants
Race (NIH/OMB) More than one race	2 Participants n=485 Participants	1 Participants n=484 Participants	0 Participants n=485 Participants	3 Participants n=1454 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=485 Participants	3 Participants n=484 Participants	2 Participants n=485 Participants	7 Participants n=1454 Participants
Geographic Region United States / Canada	226 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	224 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	226 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	676 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
Geographic Region Japan	57 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	60 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	59 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	176 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
Geographic Region Europe / Australia / New Zealand	163 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	163 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	161 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	487 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
Geographic Region Other	37 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	37 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	38 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	112 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
APOE4 Genotype Negative	155 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	146 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	148 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	449 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
APOE4 Genotype Positive	328 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	337 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	335 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	1000 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
APOE4 Genotype Missing	0 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	1 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	1 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	2 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
Baseline Use of Vitamin E No Use	351 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	372 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	355 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	1078 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
Baseline Use of Vitamin E ≤400 IU / day	123 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	100 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	120 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	343 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
Baseline Use of Vitamin E >400 IU / day	9 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	12 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	9 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	30 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
Background Alzheimer's Disease (AD) Treatment Use of AChEI alone	182 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	191 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	180 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	553 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
Background Alzheimer's Disease (AD) Treatment Use of memantine alone	9 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	8 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	8 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	25 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
Background Alzheimer's Disease (AD) Treatment Use of AChEI and memantine	31 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	26 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	34 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	91 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
Background Alzheimer's Disease (AD) Treatment No use of AChEI or memantine	261 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	259 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	262 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	782 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
Mini-Mental State Examination (MMSE) Score MMSE ≥27	212 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	211 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	214 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	637 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
Mini-Mental State Examination (MMSE) Score MMSE ≥24-26	270 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	271 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	270 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	811 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
Mini-Mental State Examination (MMSE) Score Missing	1 Participants n=483 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	2 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	0 Participants n=484 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.	3 Participants n=1451 Participants • Includes all randomized participants receiving ≥1 dose of study treatment.
Clinical Dementia Rating Sum of Boxes (CDR-SB) Score	2.7 Score on a Scale STANDARD_DEVIATION 1.3 • n=465 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose CDR-SB observation; and 2) tested positive for cortical amyloid load by positron emission tomography (PET).	2.7 Score on a Scale STANDARD_DEVIATION 1.3 • n=458 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose CDR-SB observation; and 2) tested positive for cortical amyloid load by positron emission tomography (PET).	2.6 Score on a Scale STANDARD_DEVIATION 1.2 • n=469 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose CDR-SB observation; and 2) tested positive for cortical amyloid load by positron emission tomography (PET).	2.66 Score on a Scale STANDARD_DEVIATION 1.25 • n=1392 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose CDR-SB observation; and 2) tested positive for cortical amyloid load by positron emission tomography (PET).
Composite Cognition Score-3 Domain (CCS-3D)	0.0 Z-score STANDARD_DEVIATION 1.0 • n=441 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose CCS-3D observation; and 2) tested positive for cortical amyloid load by PET.	0.0 Z-score STANDARD_DEVIATION 1.0 • n=424 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose CCS-3D observation; and 2) tested positive for cortical amyloid load by PET.	-0.1 Z-score STANDARD_DEVIATION 1.0 • n=440 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose CCS-3D observation; and 2) tested positive for cortical amyloid load by PET.	-0.01 Z-score STANDARD_DEVIATION 1.00 • n=1305 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose CCS-3D observation; and 2) tested positive for cortical amyloid load by PET.
Total Hippocampal Volume (THV)	6448.4 µL STANDARD_DEVIATION 1107.1 • n=168 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose THV observation; and 2) tested positive for cortical amyloid load by PET.	6468.5 µL STANDARD_DEVIATION 1105.8 • n=181 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose THV observation; and 2) tested positive for cortical amyloid load by PET.	6435.4 µL STANDARD_DEVIATION 987.2 • n=191 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose THV observation; and 2) tested positive for cortical amyloid load by PET.	6450.55 µL STANDARD_DEVIATION 1063.87 • n=540 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose THV observation; and 2) tested positive for cortical amyloid load by PET.
[18F]Flutemetamol Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVR)	0.86 Standard Uptake Value Ratio (SUVR) STANDARD_DEVIATION 0.07 • n=63 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose SUVR observation; and 2) tested positive for cortical amyloid load by PET. SUVR testing occurred at select sites as a Part 1 substudy.	0.87 Standard Uptake Value Ratio (SUVR) STANDARD_DEVIATION 0.07 • n=59 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose SUVR observation; and 2) tested positive for cortical amyloid load by PET. SUVR testing occurred at select sites as a Part 1 substudy.	0.85 Standard Uptake Value Ratio (SUVR) STANDARD_DEVIATION 0.06 • n=65 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose SUVR observation; and 2) tested positive for cortical amyloid load by PET. SUVR testing occurred at select sites as a Part 1 substudy.	0.86 Standard Uptake Value Ratio (SUVR) STANDARD_DEVIATION 0.07 • n=187 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose SUVR observation; and 2) tested positive for cortical amyloid load by PET. SUVR testing occurred at select sites as a Part 1 substudy.
AD Cooperative Study-Activities of Daily Living, Mild Cognitive Impairment (ADCS-ADL MCI) Score	42.2 Score on a Scale STANDARD_DEVIATION 5.9 • n=469 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose ADCS-ADL MCI observation; and 2) tested positive for cortical amyloid load by PET.	43.1 Score on a Scale STANDARD_DEVIATION 5.4 • n=462 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose ADCS-ADL MCI observation; and 2) tested positive for cortical amyloid load by PET.	42.8 Score on a Scale STANDARD_DEVIATION 5.9 • n=472 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose ADCS-ADL MCI observation; and 2) tested positive for cortical amyloid load by PET.	42.71 Score on a Scale STANDARD_DEVIATION 5.73 • n=1403 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose ADCS-ADL MCI observation; and 2) tested positive for cortical amyloid load by PET.
Cerebrospinal Fluid (CSF) Total Tau Concentration	203.8 pg/mL STANDARD_DEVIATION 129.1 • n=5 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose observation for CSF Total Tau concentration; and 2) tested positive for cortical amyloid load by PET. CSF Total Tau concentration was analyzed at select trial sites as a Part 1 substudy.	159.3 pg/mL STANDARD_DEVIATION 79.0 • n=6 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose observation for CSF Total Tau concentration; and 2) tested positive for cortical amyloid load by PET. CSF Total Tau concentration was analyzed at select trial sites as a Part 1 substudy.	243.5 pg/mL STANDARD_DEVIATION 97.0 • n=6 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose observation for CSF Total Tau concentration; and 2) tested positive for cortical amyloid load by PET. CSF Total Tau concentration was analyzed at select trial sites as a Part 1 substudy.	202.12 pg/mL STANDARD_DEVIATION 101.91 • n=17 Participants • Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose observation for CSF Total Tau concentration; and 2) tested positive for cortical amyloid load by PET. CSF Total Tau concentration was analyzed at select trial sites as a Part 1 substudy.