Trial Outcomes & Findings for A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH) (NCT NCT03496207)

NCT ID: NCT03496207

Last Updated: 2023-04-19

Results Overview

Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and at 24 weeks.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 106 participants
• Primary outcome timeframe: Baseline and 24 weeks
• Results posted on: 2023-04-19

Participant Flow

Participant milestones

Measure	Extension Period: Placebo→Sotatercept 0.3 mg/kg This treatment group represents participants from the Placebo arm who received placebo plus standard of care (SOC) by subcutaneous (SC) injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.3 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Placebo→Sotatercept 0.7 mg/kg This treatment group represents participants from the Placebo arm who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.7 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.	Placebo Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) and 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) and 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study STARTED	0	0	32	32	42
Base Study COMPLETED	0	0	30	31	36
Base Study NOT COMPLETED	0	0	2	1	6
Extension Period STARTED	15	15	0	31	36
Extension Period COMPLETED	13	15	0	28	31
Extension Period NOT COMPLETED	2	0	0	3	5

Reasons for withdrawal

Measure	Extension Period: Placebo→Sotatercept 0.3 mg/kg This treatment group represents participants from the Placebo arm who received placebo plus standard of care (SOC) by subcutaneous (SC) injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.3 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Placebo→Sotatercept 0.7 mg/kg This treatment group represents participants from the Placebo arm who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.7 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.	Placebo Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) and 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) and 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study Adverse Event	0	0	1	1	4
Base Study Death	0	0	0	0	1
Base Study Withdrawal by Subject	0	0	1	0	1
Extension Period Adverse Event	0	0	0	1	1
Extension Period Death	1	0	0	1	2
Extension Period Withdrawal by Subject	1	0	0	1	1
Extension Period Elevated hemoglobin levels	0	0	0	0	1

Baseline Characteristics

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)

Baseline characteristics by cohort

Measure	Placebo n=32 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=32 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) and 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=42 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) and 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Total n=106 Participants Total of all reporting groups
Age, Continuous	45.6 Years STANDARD_DEVIATION 13.38 • n=5 Participants	49.1 Years STANDARD_DEVIATION 14.34 • n=7 Participants	49.8 Years STANDARD_DEVIATION 15.05 • n=5 Participants	48.3 Years STANDARD_DEVIATION 14.33 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	29 Participants n=7 Participants	37 Participants n=5 Participants	92 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	32 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	19 Participants n=7 Participants	28 Participants n=5 Participants	68 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	31 Participants n=7 Participants	37 Participants n=5 Participants	98 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 24 weeks

Population: All randomized participants administered their assigned treatment who received at least 6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and End of Treatment (EOT) assessment. Note: Data from participants whose dose was down-titrated were analyzed according to dose received at least 6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed.

Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and at 24 weeks.

Outcome measures

Measure	Placebo n=30 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=27 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=30 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks Base Study: Change from Baseline in PVR at 24 Weeks	-27.6 dynes*sec/cm^5 Standard Deviation 251.08	-168.4 dynes*sec/cm^5 Standard Deviation 262.93	-258.9 dynes*sec/cm^5 Standard Deviation 169.42	—
Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks Baseline	802.0 dynes*sec/cm^5 Standard Deviation 331.05	772.0 dynes*sec/cm^5 Standard Deviation 285.62	715.5 dynes*sec/cm^5 Standard Deviation 267.11	—

PRIMARY outcome

Timeframe: Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24

Population: All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for the respective timepoints

Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.

Outcome measures

Measure	Placebo n=30 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=67 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Extension Period: Change From Baseline in PVR (Delayed-Start Analysis) Extension Period: Change from Baseline in PVR (Delayed-Start Analysis)	-246.9 dynes*sec/cm^5 Standard Deviation 300.01	-212.6 dynes*sec/cm^5 Standard Deviation 254.24	—	—
Extension Period: Change From Baseline in PVR (Delayed-Start Analysis) Baseline	802.0 dynes*sec/cm^5 Standard Deviation 331.05	783.7 dynes*sec/cm^5 Standard Deviation 371.59	—	—

PRIMARY outcome

Timeframe: Baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.

Population: All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for the respective timepoints

Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.

Outcome measures

Measure	Placebo n=30 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Extension Period: Change From Baseline in PVR (Placebo-Crossed Analysis) Extension Period: Change from Baseline in PVR (Placebo-Crossed Analysis)	-246.9 dynes*sec/cm^5 Standard Deviation 300.01	—	—	—
Extension Period: Change From Baseline in PVR (Placebo-Crossed Analysis) Baseline	802.0 dynes*sec/cm^5 Standard Deviation 331.05	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 32 months

Population: All randomized participants who transitioned to the extension period and received at least 1 dose of study treatment

An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that 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 related to the medicinal product.

Outcome measures

Measure	Placebo n=15 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=15 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=31 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg n=36 Participants Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Extension Period: Number of Participants Who Experienced One or More Adverse Events (AEs)	14 Participants	15 Participants	31 Participants	36 Participants

PRIMARY outcome

Timeframe: Up to 30 months

Population: All randomized participants who transitioned to the extension period and received at least 1 dose of study treatment

An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that 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 related to the medicinal product.

Outcome measures

Measure	Placebo n=15 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=15 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=31 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg n=36 Participants Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Extension Period: Number of Participants Who Discontinued Study Treatment Due to an AE	1 Participants	0 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: All randomized participants administered their assigned treatment who received at least 6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment. Note: Data from participants whose dose was down-titrated were analyzed according to dose received at least 6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed.

6MWD is measured by an exercise test known as 6-Minute Walk Test (6MWT) that assesses aerobic capacity and endurance. It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity. Each participant's 6MWD was measured at baseline and at 24 weeks. An increase in the distance walked during the 6MWT indicates improvement in basic mobility.

Outcome measures

Measure	Placebo n=30 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=27 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=30 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study: Change From Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks	31.4 meters Standard Error 9.69	56.0 meters Standard Error 10.07	53.6 meters Standard Error 9.84	—

SECONDARY outcome

Timeframe: Baseline and 24 Weeks

Population: All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed.

Each participant's laboratory biomarkers N-terminal prohormone brain-type natriuretic peptide (NT-proBNP) or brain-type natriuretic peptide (BNP) were measured at baseline and at 24 weeks.

Outcome measures

Measure	Placebo n=29 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=25 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=28 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study: Change From Baseline in Concentration of Amino-Terminal Brain Natriuretic Propeptide (NT-proBNP) at 24 Weeks	195.9 pg/mL Standard Deviation 726.46	-718.2 pg/mL Standard Deviation 965.12	-359.0 pg/mL Standard Deviation 757.58	—

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed.

Each participant's TAPSE, which is commonly used to evaluate tricuspid valve annulus movement as an indicator of right heart function, was measured by echocardiography at baseline and 24 weeks.

Outcome measures

Measure	Placebo n=28 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=24 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=28 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study: Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at 24 Weeks	0.0 cm Standard Deviation 0.39	0.1 cm Standard Deviation 0.26	-0.1 cm Standard Deviation 0.34	—

SECONDARY outcome

Timeframe: Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)

Population: All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed.

The CAMPHOR is participant-reported questionnaire that contains 65 items in total, 25 relating to symptoms, 25 relating to quality of life (QoL), and 15 relating to activities. Symptom items are scored from 0-25, with a higher score indicating worse symptoms. QoL items are also scored from 0-25, with a higher score indicating a worse QoL and greater functional limitation. Activity items are scored from 0-30, with a higher score indicating poorer functioning. The combined score is obtained by summing up the symptoms score, QoL score and activity score. The lowest combined score possible is 0, while the highest combined score possible is 80. Each participant's CAMPHOR score was recorded at baseline and on Day 1 of Cycle 9.

Outcome measures

Measure	Placebo n=29 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=23 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=21 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study: Change From Baseline in Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Score at Cycle 9	-10.2 Score on a scale Standard Deviation 12.91	-6.9 Score on a scale Standard Deviation 12.51	-7.5 Score on a scale Standard Deviation 7.96	—

SECONDARY outcome

Timeframe: Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)

Population: All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed.

The SF-36 questionnaire is a participant-reported survey of a participant's health. The survey evaluates 8 aspects of functional health and well-being that relate to either physical health or mental health. The physical component summary is based primarily on physical functioning, bodily pain, and general health. The mental component summary encompasses vitality, social functioning, and emotional and mental health. Total scores for the physical component range from 0-100, with 100 representing the highest level of physical functioning. The total scores for the mental component also range from 0-100, with 100 representing the highest level of mental functioning. Each participant's SF-36 was recorded at baseline and on Day 1 of Cycle 9. Each cycle was 21 days.

Outcome measures

Measure	Placebo n=30 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=27 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=29 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score Physical component	3.5 Score on a scale Standard Error 1.07	4.5 Score on a scale Standard Error 1.12	3.1 Score on a scale Standard Error 1.11	—
Base Study: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score Mental component	3.2 Score on a scale Standard Error 1.33	3.6 Score on a scale Standard Error 1.39	0.0 Score on a scale Standard Error 1.40	—

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: All randomized participants who received their assigned treatment and had data for Base Study: Number of Participants Who Experienced Events Indicative of Clinical Worsening of PAH

Events that indicate clinical worsening of PAH include death, need for and/or worsening-related listing for lung and/or heart transplant, need to initiate an approved PAH SOC rescue therapy, PAH-specific hospitalization, or functional deterioration (worsened WHO Functional Class AND 15% decrease in 6MWD).

Outcome measures

Measure	Placebo n=32 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=32 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=42 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study: Number of Participants Who Experienced Events Indicative of Clinical Worsening of Pulmonary Arterial Hypertension (PAH)	2 Participants	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Baseline and 24 Weeks

Population: All randomized participants who received their assigned treatment and at least 6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for Base Study: Number of Participants Who Experienced an Improvement from Baseline in WHO Functional Class at 24 Weeks. Note: Data from participants whose dose was down-titrated were analyzed according to dose received at least 6 times rather than dose to which originally assigned.

The WHO Functional Class describes the severity of a person's pulmonary hypertension symptoms. There are four different classes: I is the mildest and IV the most severe form of pulmonary hypertension.

Outcome measures

Measure	Placebo n=30 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=27 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=30 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study: Number of Participants Who Experienced an Improvement From Baseline in World Health Organization (WHO) Functional Class at 24 Weeks	4 Participants	8 Participants	6 Participants	—

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: All randomized participants who received at least 1 dose of study treatment

An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that 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 related to the medicinal product.

Outcome measures

Measure	Placebo n=32 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=32 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=42 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study: Number of Participants Who Experienced One or More AEs	29 Participants	29 Participants	35 Participants	—

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: All randomized participants who received at least 1 dose of study treatment

An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that 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 related to the medicinal product.

Outcome measures

Measure	Placebo n=32 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=32 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=42 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study: Number of Participants Who Discontinued Study Treatment Due to an AE	1 Participants	1 Participants	5 Participants	—

SECONDARY outcome

Timeframe: Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)

Population: All randomized participants who received their assigned treatment and had data for Base Study: Change from Baseline in BMI at Cycle 9

Each participant's BMI was measured at baseline and at 24 weeks.

Outcome measures

Measure	Placebo n=30 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=31 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=36 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study: Change From Baseline in Body Mass Index (BMI) at Cycle 9	-0.2 kg/m^2 Standard Deviation 1.25	0.6 kg/m^2 Standard Deviation 0.89	0.2 kg/m^2 Standard Deviation 1.07	—

SECONDARY outcome

Timeframe: Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)

Population: All randomized participants who received their assigned treatment and had data for Base Study: Change from Baseline in Systolic and Diastolic Blood Pressure at Cycle 9

Each participant's systolic and diastolic blood pressure was taken at baseline and on Day 1 of Cycle 9. Each cycle was 21 days.

Outcome measures

Measure	Placebo n=30 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=31 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=36 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study: Change From Baseline in Systolic and Diastolic Blood Pressure at Cycle 9 Systolic blood pressure	-0.8 mmHg Standard Deviation 10.06	3.4 mmHg Standard Deviation 11.75	2.6 mmHg Standard Deviation 12.28	—
Base Study: Change From Baseline in Systolic and Diastolic Blood Pressure at Cycle 9 Diastolic blood pressure	2.3 mmHg Standard Deviation 8.06	4.1 mmHg Standard Deviation 8.64	1.7 mmHg Standard Deviation 8.69	—

SECONDARY outcome

Timeframe: Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)

Population: All randomized participants who received their assigned treatment and had data for Base Study: Change from Baseline in Respiratory Rate at Cycle 9

Each participant's respiratory rate (number of breaths per minute) was measured at baseline and on Day 1 of Cycle 9. Each cycle was 21 days.

Outcome measures

Measure	Placebo n=29 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=31 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=36 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study: Change From Baseline in Respiratory Rate at Cycle 9	-0.3 breaths/min Standard Deviation 2.10	-1.3 breaths/min Standard Deviation 3.72	-0.3 breaths/min Standard Deviation 3.05	—

SECONDARY outcome

Timeframe: Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)

Population: All randomized participants who received their assigned treatment and had data for Base Study: Change from Baseline in QTcF Interval at Cycle 9

Each participant's QTcF Interval was measured at baseline and on Day 1 of Cycle 9.

Outcome measures

Measure	Placebo n=30 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=31 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg n=35 Participants Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study: Change From Baseline in QTcF Interval at Cycle 9	0.7 milliseconds Standard Deviation 31.10	-7.4 milliseconds Standard Deviation 20.57	-9.1 milliseconds Standard Deviation 31.55	—

SECONDARY outcome

Timeframe: Day 8 of Cycle 1 (Each cycle was 21 days.)

Population: All randomized participants who received at least 1 dose of sotatercept and had sufficient pharmacokinetic samples collected and assayed for PK analysis

Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Based on population pharmacokinetic (PopPK) modeling of previous sotatercept studies, Cmax occurs at Day 8 of Cycle 1 after a sotatercept dose is given. The sotatercept concentration at Day 8 of Cycle 1 (each cycle was 21 days) is presented here as Cmax.

Outcome measures

Measure	Placebo n=32 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=42 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Base Study: Maximum Plasma Concentration (Cmax) of Sotatercept	1910.3 ng/mL Standard Deviation 715.86	4598.5 ng/mL Standard Deviation 1622.59	—	—

SECONDARY outcome

Timeframe: Baseline and the timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24

Population: All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for Extension Period: Change from Baseline in 6MWD (Delayed-Start Analysis)

6MWD is measured by an exercise test known as 6MWT that assesses aerobic capacity and endurance. It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity. Each participant's 6MWD was measured at baseline and the timepoint at which the third RCH was performed. This occurred between Month 18 and Month 24, at which time each participant's 6MWD was also measured. An increase in the distance walked during the 6MWT indicates improvement in basic mobility.

Outcome measures

Measure	Placebo n=30 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=67 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Extension Period: Change From Baseline in 6MWD (Delayed-Start Analysis)	60.1 meters Standard Error 14.35	55.7 meters Standard Error 9.47	—	—

SECONDARY outcome

Timeframe: Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24

Population: All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for Extension Period: Change from Baseline in 6MWD (Placebo-Crossed Analysis)

6MWD is measured by an exercise test known as 6MWT that assesses aerobic capacity and endurance. It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity. Each participant's 6MWD was measured at baseline and the timepoint at which the third right heart catheterization was performed. This occurred between Month 18 and Month 24, at which time each participant's 6MWD was also measured. An increase in the distance walked during the 6MWT indicates improvement in basic mobility.

Outcome measures

Measure	Placebo n=30 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Extension Period: Change From Baseline in 6MWD (Placebo-Crossed Analysis)	60.5 meters Standard Error 13.21	—	—	—

SECONDARY outcome

Timeframe: Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24

Population: All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for Extension Period: Number of Participants Who Experienced an Improvement from Baseline in WHO Functional Class (Delayed-Start Analysis)

The WHO Functional Class describes the severity of a person's pulmonary hypertension symptoms. There are four different classes: I is the mildest and IV the most severe form of pulmonary hypertension. Each participant's WHO Functional Class was assessed at baseline and the timepoint at which the third right heart catheterization was performed. This occurred between Month 18 and Month 24, at which time each participant's WHO Functional Class was also assessed.

Outcome measures

Measure	Placebo n=29 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg n=66 Participants Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Extension Period: Number of Participants Who Experienced an Improvement From Baseline in WHO Functional Class (Delayed-Start Analysis)	16 Participants	27 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24

Population: All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for Extension Period: Change from Baseline in WHO Functional Class (Placebo-Crossed Analysis)

The WHO Functional Class describes the severity of a person's pulmonary hypertension symptoms. There are four different classes: I is the mildest and IV the most severe form of pulmonary hypertension. Each participant's WHO Functional Class was assessed at baseline and the timepoint at which the third right heart catheterization was performed. This occurred between Month 18 and Month 24, at which time each participant's WHO Functional Class was also assessed.

Outcome measures

Measure	Placebo n=28 Participants Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.3 mg/kg Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Sotatercept 0.7 mg/kg Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Extension Period: Change From Baseline in WHO Functional Class (Placebo-Crossed Analysis)	-0.6 WHO functional class Standard Deviation 0.74	—	—	—

Adverse Events

Base Study: Placebo

Serious events: 3 serious events

Other events: 25 other events

Deaths: 0 deaths

Base Study: Sotatercept 0.3 mg/kg

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Base Study: Sotatercept 0.7 mg/kg

Serious events: 10 serious events

Other events: 33 other events

Deaths: 1 deaths

Extension Period: Placebo→Sotatercept 0.3 mg/kg

Serious events: 6 serious events

Other events: 14 other events

Deaths: 1 deaths

Extension Period: Placebo→Sotatercept 0.7 mg/kg

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Extension Period: Sotatercept 0.3 mg/kg

Serious events: 10 serious events

Other events: 30 other events

Deaths: 1 deaths

Extension Period: Sotatercept 0.7 mg/kg

Serious events: 12 serious events

Other events: 36 other events

Deaths: 2 deaths

Serious adverse events

Measure	Base Study: Placebo n=32 participants at risk Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Base Study: Sotatercept 0.3 mg/kg n=32 participants at risk Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Base Study: Sotatercept 0.7 mg/kg n=42 participants at risk Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Placebo→Sotatercept 0.3 mg/kg n=15 participants at risk This treatment group represents participants from the Placebo arm who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.3 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Placebo→Sotatercept 0.7 mg/kg n=15 participants at risk This treatment group represents participants from the Placebo arm who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.7 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.3 mg/kg n=31 participants at risk Participants who received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.3 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg n=36 participants at risk Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Nervous system disorders Syncope	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Neuropathy peripheral	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Presyncope	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Blood and lymphatic system disorders Anaemia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Blood and lymphatic system disorders Leukopenia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Blood and lymphatic system disorders Neutropenia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Atrial fibrillation	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Atrial flutter	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Cardiac arrest	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Pericardial effusion	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Right ventricular failure	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Tachyarrhythmia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Tachycardia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Tachycardia paroxysmal	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Eye disorders Chorioretinopathy	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Chest discomfort	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Fatigue	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Malaise	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Oedema peripheral	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Pyrexia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Vessel puncture site haematoma	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Brain abscess	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Bronchitis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Catheter site infection	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Device related infection	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Device related sepsis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Gastroenteritis	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Gastrointestinal infection	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Influenza	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Infusion site infection	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Lower respiratory tract infection	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Pneumonia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Pneumonia viral	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Pyelonephritis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Respiratory tract infection	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Sepsis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Septic embolus	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Tuberculosis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Urinary tract infection	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Investigations Red blood cell count increased	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Ischaemic stroke	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Migraine	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Product Issues Device breakage	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Product Issues Device dislocation	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Product Issues Device malfunction	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Product Issues Device occlusion	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 8 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Vascular disorders Hypotension	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.

Other adverse events

Measure	Base Study: Placebo n=32 participants at risk Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Base Study: Sotatercept 0.3 mg/kg n=32 participants at risk Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Base Study: Sotatercept 0.7 mg/kg n=42 participants at risk Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Placebo→Sotatercept 0.3 mg/kg n=15 participants at risk This treatment group represents participants from the Placebo arm who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.3 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Placebo→Sotatercept 0.7 mg/kg n=15 participants at risk This treatment group represents participants from the Placebo arm who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.7 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.3 mg/kg n=31 participants at risk Participants who received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.3 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.	Extension Period: Sotatercept 0.7 mg/kg n=36 participants at risk Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Eye disorders Glaucoma	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Eye disorders Dry eye	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Eye disorders Dacryostenosis acquired	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Eye disorders Deposit eye	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Blood and lymphatic system disorders Anaemia	6.2% 2/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	4.8% 2/42 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	25.8% 8/31 • Number of events 13 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Blood and lymphatic system disorders Iron deficiency anaemia	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	26.7% 4/15 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Blood and lymphatic system disorders Leukopenia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Blood and lymphatic system disorders Neutropenia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Blood and lymphatic system disorders Polycythaemia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	11.9% 5/42 • Number of events 8 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.7% 3/31 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 8 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Angina pectoris	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Atrial fibrillation	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Bradycardia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Cardiac failure	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Low cardiac output syndrome	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Palpitations	9.4% 3/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Pericardial effusion	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Right ventricular failure	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Sinus tachycardia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Tachycardia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Cardiac disorders Tachycardia paroxysmal	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Ear and labyrinth disorders Ear pain	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Ear and labyrinth disorders Tinnitus	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Ear and labyrinth disorders Vertigo	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.7% 3/31 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Endocrine disorders Hypothyroidism	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Eye disorders Cataract	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Eye disorders Keratitis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Eye disorders Periorbital oedema	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Abdominal distension	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Abdominal pain	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.7% 3/31 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Abdominal pain upper	3.1% 1/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Constipation	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.7% 3/31 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Crohn's disease	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Defaecation urgency	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Dental plaque	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Diarrhoea	15.6% 5/32 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	21.9% 7/32 • Number of events 8 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	14.3% 6/42 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	33.3% 5/15 • Number of events 7 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	29.0% 9/31 • Number of events 14 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.9% 5/36 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Dry mouth	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	4.8% 2/42 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Dyspepsia	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Gastritis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Gingival bleeding	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Haematochezia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Haemorrhoids	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Large intestine polyp	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Nausea	15.6% 5/32 • Number of events 9 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.4% 3/32 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	11.9% 5/42 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	26.7% 4/15 • Number of events 9 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	29.0% 9/31 • Number of events 11 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.9% 5/36 • Number of events 7 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Peptic ulcer	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Proctalgia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Vomiting	12.5% 4/32 • Number of events 10 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.4% 3/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	7.1% 3/42 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	19.4% 6/31 • Number of events 9 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	11.1% 4/36 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Application site pain	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Asthenia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Catheter site haemorrhage	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Chest discomfort	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Chest pain	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Chills	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Cyst	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Discomfort	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Face oedema	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Musculoskeletal and connective tissue disorders Fracture pain	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Fatigue	18.8% 6/32 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.5% 4/42 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	40.0% 6/15 • Number of events 7 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	26.7% 4/15 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	19.4% 6/31 • Number of events 9 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.9% 5/36 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Feeling abnormal	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Infusion site pain	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Injection site erythema	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Injection site pain	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.5% 4/42 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Injection site pruritus	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Localised oedema	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Non-cardiac chest pain	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Oedema peripheral	15.6% 5/32 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.4% 3/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	11.9% 5/42 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	26.7% 4/15 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	40.0% 6/15 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	35.5% 11/31 • Number of events 12 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	19.4% 7/36 • Number of events 8 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Pain	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Pyrexia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	16.1% 5/31 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Vessel puncture site haematoma	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Hepatobiliary disorders Gallbladder polyp	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Bronchitis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.7% 3/31 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations COVID-19	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.7% 3/31 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.9% 5/36 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Conjunctivitis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Cystitis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Ear infection	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Fungal pharyngitis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Gastroenteritis	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.5% 4/42 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	16.1% 5/31 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Gingivitis	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Herpes zoster	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Hordeolum	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Influenza	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.9% 5/36 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Labyrinthitis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Nasopharyngitis	9.4% 3/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.5% 4/42 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	33.3% 5/15 • Number of events 9 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	40.0% 6/15 • Number of events 7 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	32.3% 10/31 • Number of events 14 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Onychomycosis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Oral candidiasis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Oral herpes	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Otitis externa	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Pharyngitis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Respiratory tract infection	9.4% 3/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Rhinitis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Sinusitis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Tinea pedis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Tonsillitis bacterial	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Tooth infection	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Upper respiratory tract infection	9.4% 3/32 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	12.5% 4/32 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	4.8% 2/42 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	19.4% 6/31 • Number of events 9 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	16.7% 6/36 • Number of events 8 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Urinary tract infection	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.4% 3/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	16.1% 5/31 • Number of events 7 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.9% 5/36 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Animal bite	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Contusion	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Fall	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	16.1% 5/31 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Head injury	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Limb injury	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Post-traumatic neck syndrome	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Investigations Alanine aminotransferase increased	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	4.8% 2/42 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Investigations Aspartate aminotransferase increased	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Investigations Blood bicarbonate decreased	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Investigations Blood chloride increased	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Investigations Blood pressure increased	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Investigations Blood sodium decreased	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Investigations Glomerular filtration rate decreased	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Investigations Haematocrit increased	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Investigations Haemoglobin decreased	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Investigations Haemoglobin increased	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	16.7% 7/42 • Number of events 7 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	33.3% 5/15 • Number of events 7 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.9% 5/36 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Investigations Intraocular pressure increased	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Investigations Reticulocyte count increased	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Investigations Urine albumin/creatinine ratio increased	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Metabolism and nutrition disorders Decreased appetite	9.4% 3/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Metabolism and nutrition disorders Fluid retention	3.1% 1/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Metabolism and nutrition disorders Folate deficiency	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Metabolism and nutrition disorders Gout	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Metabolism and nutrition disorders Hypokalaemia	12.5% 4/32 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.4% 3/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	11.9% 5/42 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	12.9% 4/31 • Number of events 8 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Metabolism and nutrition disorders Iron deficiency	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.7% 3/31 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	16.7% 6/36 • Number of events 8 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Musculoskeletal and connective tissue disorders Arthralgia	15.6% 5/32 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	33.3% 5/15 • Number of events 9 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	25.8% 8/31 • Number of events 12 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.9% 5/36 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Musculoskeletal and connective tissue disorders Back pain	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.4% 3/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	22.6% 7/31 • Number of events 10 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Musculoskeletal and connective tissue disorders Exostosis	3.1% 1/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.5% 4/42 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	12.9% 4/31 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Musculoskeletal and connective tissue disorders Myalgia	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	7.1% 3/42 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	12.9% 4/31 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	11.1% 4/36 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.4% 3/32 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	11.9% 5/42 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	25.8% 8/31 • Number of events 11 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Dizziness	9.4% 3/32 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	15.6% 5/32 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.5% 4/42 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	26.7% 4/15 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	12.9% 4/31 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.9% 5/36 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Facial paralysis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Headache	18.8% 6/32 • Number of events 10 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	25.0% 8/32 • Number of events 16 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	14.3% 6/42 • Number of events 8 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	26.7% 4/15 • Number of events 21 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	46.7% 7/15 • Number of events 13 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	29.0% 9/31 • Number of events 16 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	16.7% 6/36 • Number of events 10 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Hypoaesthesia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Intention tremor	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Lethargy	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Migraine	3.1% 1/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Paraesthesia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	11.1% 4/36 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Presyncope	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Sciatica	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Syncope	9.4% 3/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Tension headache	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Tremor	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Product Issues Device dislocation	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Product Issues Device leakage	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Product Issues Device occlusion	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Psychiatric disorders Anxiety	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Psychiatric disorders Depression	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	16.1% 5/31 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Psychiatric disorders Insomnia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Psychiatric disorders Procedural anxiety	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Renal and urinary disorders Calculus urinary	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Renal and urinary disorders Haematuria	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Renal and urinary disorders Microalbuminuria	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Renal and urinary disorders Proteinuria	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	9.7% 3/31 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Reproductive system and breast disorders Breast hyperplasia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Reproductive system and breast disorders Breast mass	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Reproductive system and breast disorders Breast swelling	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Reproductive system and breast disorders Vaginal ulceration	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	12.9% 4/31 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.1% 1/32 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	16.1% 5/31 • Number of events 8 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	12.5% 4/32 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	11.9% 5/42 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 7 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	26.7% 4/15 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	22.6% 7/31 • Number of events 10 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	11.1% 4/36 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Nasal turbinate hypertrophy	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	20.0% 3/15 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Skin and subcutaneous tissue disorders Acne	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	5.6% 2/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Skin and subcutaneous tissue disorders Erythema	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Skin and subcutaneous tissue disorders Pruritus	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Skin and subcutaneous tissue disorders Rash	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Skin and subcutaneous tissue disorders Telangiectasia	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	26.7% 4/15 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	33.3% 5/15 • Number of events 6 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	16.1% 5/31 • Number of events 5 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	19.4% 7/36 • Number of events 8 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Vascular disorders Deep vein thrombosis	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/36 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Vascular disorders Flushing	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.4% 1/42 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.2% 1/31 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Vascular disorders Haematoma	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/31 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Vascular disorders Hypertension	0.00% 0/32 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 1 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/42 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 1/15 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	12.9% 4/31 • Number of events 4 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	8.3% 3/36 • Number of events 3 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
Vascular disorders Hypotension	6.2% 2/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	3.1% 1/32 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	4.8% 2/42 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	0.00% 0/15 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	13.3% 2/15 • Number of events 12 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	6.5% 2/31 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.	2.8% 1/36 • Number of events 2 • Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months. The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor will comply with the requirements for publication of study results. In accordance with standard editorial and ethical practice, the sponsor will generally support publication.
• Publication restrictions are in place

Restriction type: OTHER