Trial Outcomes & Findings for A Study of the Efficacy and Safety of Frespaciguat (MK-5475) in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007) (NCT NCT04732221)

Last Updated: 2025-05-25

Results Overview

PVR was calculated in participants after MK-5475 dosing at baseline and Week 12. PVR is assessed by right heart catheterization (RHC). Based on the variables obtained by right heart catheterization (RHC), the percentage change from baseline PVR was calculated. Per protocol, this outcome measure was assessed only for base period and was not assessed during extension period.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

168 participants

Primary outcome timeframe

At baseline and 12 weeks

Results posted on

2025-05-25

Participant Flow

The study was planned to be conducted in 2 parts: a Phase 2 dose selection cohort and a Phase 3 confirmatory cohort. Due to sponsor's decision, Phase 3 was not conducted.

Participant milestones

Participant milestones
Measure	Base Period: Placebo Participants received placebo via oral inhalation once daily for 12 week base period	Base Period: MK-5475 32 µg Participants received MK-5475 32 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 100 µg Participants received MK-5475 100 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 380 µg Participants receive MK-5475 380 µg via oral inhalation once daily for 12 week base period	Extension Period: MK-5475 32 µg Participants who received MK-3475 32 ug in the base period, and participants who received placebo in the base period and were randomized to the 32 ug group in the extension period, were administered MK-3475 32ug via oral inhalation for up to 25 months	Extension Period: MK-5475 100 µg Participants who received MK-3475 100 ug in the base period, and participants who received placebo in the base period and were randomized to the 100 ug group in the extension period, were administered MK-3475 100 ug via oral inhalation for up to 25 months	Extension Period: MK-5475 380 μg Participants who received MK-3475 380 ug in the base period, and participants who received placebo in the base period and were randomized to the 380 ug group in the extension period, were administered MK-3475 380 ug via oral inhalation for up to 25 months
Base Period STARTED	41	42	44	41	0	0	0
Base Period COMPLETED	39	41	43	41	0	0	0
Base Period NOT COMPLETED	2	1	1	0	0	0	0
Extension Period STARTED	0	0	0	0	45	46	44
Extension Period COMPLETED	0	0	0	0	1	0	0
Extension Period NOT COMPLETED	0	0	0	0	44	46	44

Reasons for withdrawal

Reasons for withdrawal
Measure	Base Period: Placebo Participants received placebo via oral inhalation once daily for 12 week base period	Base Period: MK-5475 32 µg Participants received MK-5475 32 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 100 µg Participants received MK-5475 100 µg via oral inhalation once daily for 12 week base period	Extension Period: MK-5475 32 µg Participants who received MK-3475 32 ug in the base period, and participants who received placebo in the base period and were randomized to the 32 ug group in the extension period, were administered MK-3475 32ug via oral inhalation for up to 25 months	Extension Period: MK-5475 100 µg Participants who received MK-3475 100 ug in the base period, and participants who received placebo in the base period and were randomized to the 100 ug group in the extension period, were administered MK-3475 100 ug via oral inhalation for up to 25 months	Extension Period: MK-5475 380 μg Participants who received MK-3475 380 ug in the base period, and participants who received placebo in the base period and were randomized to the 380 ug group in the extension period, were administered MK-3475 380 ug via oral inhalation for up to 25 months
Base Period Death	2	0	0	0	0	0
Base Period Withdrawal by Subject	0	1	1	0	0	0
Extension Period Adverse Event	0	0	0	0	1	0
Extension Period Death	0	0	0	1	0	2
Extension Period Pregnancy	0	0	0	1	0	0
Extension Period Sponsors Decision	0	0	0	41	40	40
Extension Period Withdrawal by Subject	0	0	0	1	5	2

Baseline Characteristics

A Study of the Efficacy and Safety of Frespaciguat (MK-5475) in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Base Period: Placebo n=41 Participants Participants received placebo via oral inhalation once daily for 12 week base period	Base Period: MK-5475 32 µg n=42 Participants Participants received MK-5475 32 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 100 µg n=44 Participants Participants received MK-5475 100 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 380 µg n=41 Participants Participants receive MK-5475 380 µg via oral inhalation once daily for 12 week base period	Total n=168 Participants Total of all reporting groups
Age, Continuous	52.1 Years STANDARD_DEVIATION 12.7 • n=5 Participants	48.1 Years STANDARD_DEVIATION 16.9 • n=7 Participants	51.7 Years STANDARD_DEVIATION 14.2 • n=5 Participants	47.6 Years STANDARD_DEVIATION 15.9 • n=4 Participants	49.9 Years STANDARD_DEVIATION 15.0 • n=21 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	34 Participants n=7 Participants	32 Participants n=5 Participants	30 Participants n=4 Participants	124 Participants n=21 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	11 Participants n=4 Participants	44 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	12 Participants n=4 Participants	47 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	27 Participants n=7 Participants	33 Participants n=5 Participants	29 Participants n=4 Participants	119 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	34 Participants n=7 Participants	41 Participants n=5 Participants	36 Participants n=4 Participants	143 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	11 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: At baseline and 12 weeks

Population: All randomized participants who received ≥1 dose of study treatment and had baseline observation.

Outcome measures

Outcome measures
Measure	Base Period: Placebo n=41 Participants Participants received placebo via oral inhalation once daily for 12 week base period	Base Period: MK-5475 32 µg n=42 Participants Participants received MK-5475 32 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 100 µg n=44 Participants Participants received MK-5475 100 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 380 µg n=41 Participants Participants receive MK-5475 380 µg via oral inhalation once daily for 12 week base period	Extension Period: MK-5475 32 µg Participants who received MK-5475 32 μg in the base period, and those who received matching placebo for MK-5475 32 μg at the end of the base period (12 weeks) were administered MK-5475 32 μg via oral inhalation up to 25 months in the extension period	Extension Period: MK-5475 100 µg Participants who received MK-3475 100 ug in the base period, and participants who received placebo in the base period and were randomized to the 100 ug group in the extension period, were administered MK-3475 100 ug via oral inhalation for up to 25 months	Extension Period: MK-5475 380 μg Participants who received MK-3475 380 ug in the base period, and participants who received placebo in the base period and were randomized to the 380 ug group in the extension period, were administered MK-3475 380 ug via oral inhalation for up to 25 months
Phase 2 Cohort: Mean Percent Change From Baseline in Pulmonary Vascular Resistance (PVR) at 12 Weeks	4.3 Percentage Change Standard Error 4.45	-4.9 Percentage Change Standard Error 4.07	-17.6 Percentage Change Standard Error 4.07	-15.6 Percentage Change Standard Error 5.39	—	—	—

PRIMARY outcome

Timeframe: At baseline and 12 weeks

Population: Phase 3 was not conducted due to the sponsor's decision and thus no data were collected for the outcome measure.

6MWD is measured by an exercise test known as 6-Minute Walk Test (6MWT) that assesses functional capacity. It measures the distance covered over a time of 6 minutes and is intended to be used as an outcome measure by which to compare changes in excercise capacity. Each participant's 6MWD is to be measured at baseline and at 12 weeks. An increase in the distance walked during the 6MWT indicates improvement in functional exercise capacity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline and 12 weeks

Population: All randomized participants in Phase 2 who received ≥1 dose of study treatment and had baseline observation.

6MWD is measured by an exercise test known as 6-Minute Walk Test (6MWT) that assesses functional capacity. It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in exercise capacity. Each participant's 6MWD was measured at baseline and at 12 weeks. An increase in the distance walked during the 6MWT indicates improvement in functional exercise capacity.

Outcome measures

Outcome measures
Measure	Base Period: Placebo n=38 Participants Participants received placebo via oral inhalation once daily for 12 week base period	Base Period: MK-5475 32 µg n=41 Participants Participants received MK-5475 32 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 100 µg n=42 Participants Participants received MK-5475 100 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 380 µg n=40 Participants Participants receive MK-5475 380 µg via oral inhalation once daily for 12 week base period	Extension Period: MK-5475 32 µg Participants who received MK-5475 32 μg in the base period, and those who received matching placebo for MK-5475 32 μg at the end of the base period (12 weeks) were administered MK-5475 32 μg via oral inhalation up to 25 months in the extension period	Extension Period: MK-5475 100 µg Participants who received MK-3475 100 ug in the base period, and participants who received placebo in the base period and were randomized to the 100 ug group in the extension period, were administered MK-3475 100 ug via oral inhalation for up to 25 months	Extension Period: MK-5475 380 μg Participants who received MK-3475 380 ug in the base period, and participants who received placebo in the base period and were randomized to the 380 ug group in the extension period, were administered MK-3475 380 ug via oral inhalation for up to 25 months
Phase 2 Cohort: Mean Change From Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks	24.6 Meters Standard Deviation 66.3	27.4 Meters Standard Deviation 53.1	10.8 Meters Standard Deviation 45.6	11.3 Meters Standard Deviation 38.9	—	—	—

SECONDARY outcome

Timeframe: At baseline and 12 weeks

Population: All randomized participants in Phase 2 who received ≥1 dose of study treatment and had baseline observation.

mRAP is the blood pressure in the right atrium of the heart. mRAP was assessed by right heart catheterization (RHC).A decrease in mRAP indicates improvement in right ventricular function, reduction of PAH related morbidity.

Outcome measures

Outcome measures
Measure	Base Period: Placebo n=36 Participants Participants received placebo via oral inhalation once daily for 12 week base period	Base Period: MK-5475 32 µg n=41 Participants Participants received MK-5475 32 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 100 µg n=41 Participants Participants received MK-5475 100 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 380 µg n=40 Participants Participants receive MK-5475 380 µg via oral inhalation once daily for 12 week base period	Extension Period: MK-5475 32 µg Participants who received MK-5475 32 μg in the base period, and those who received matching placebo for MK-5475 32 μg at the end of the base period (12 weeks) were administered MK-5475 32 μg via oral inhalation up to 25 months in the extension period	Extension Period: MK-5475 100 µg Participants who received MK-3475 100 ug in the base period, and participants who received placebo in the base period and were randomized to the 100 ug group in the extension period, were administered MK-3475 100 ug via oral inhalation for up to 25 months	Extension Period: MK-5475 380 μg Participants who received MK-3475 380 ug in the base period, and participants who received placebo in the base period and were randomized to the 380 ug group in the extension period, were administered MK-3475 380 ug via oral inhalation for up to 25 months
Phase 2 Cohort: Mean Change From Baseline in Mean Right Atrial Pressure (mRAP) at 12 Weeks	0.3 Millimeters of Mercury (mmHg) Interval -8.0 to 9.0	0.3 Millimeters of Mercury (mmHg) Interval -17.0 to 7.0	-0.5 Millimeters of Mercury (mmHg) Interval -8.0 to 14.0	-0.1 Millimeters of Mercury (mmHg) Interval -14.0 to 12.0	—	—	—

SECONDARY outcome

Timeframe: At baseline and 12 weeks

Population: All randomized participants in Phase 2 who received ≥1 dose of study treatment and had baseline observation.

The cardiac index (CI) is a hemodynamic measure that represents the cardiac output (CO) of an individual divided by their body surface area (BSA). Cardiac index is assessed by right heart catheterization (RHC). An increase in CI is indicates better right ventricular function and is associated with a reduction of PAH related morbidity and mortality.

Outcome measures

Outcome measures
Measure	Base Period: Placebo n=37 Participants Participants received placebo via oral inhalation once daily for 12 week base period	Base Period: MK-5475 32 µg n=40 Participants Participants received MK-5475 32 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 100 µg n=41 Participants Participants received MK-5475 100 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 380 µg n=41 Participants Participants receive MK-5475 380 µg via oral inhalation once daily for 12 week base period	Extension Period: MK-5475 32 µg Participants who received MK-5475 32 μg in the base period, and those who received matching placebo for MK-5475 32 μg at the end of the base period (12 weeks) were administered MK-5475 32 μg via oral inhalation up to 25 months in the extension period	Extension Period: MK-5475 100 µg Participants who received MK-3475 100 ug in the base period, and participants who received placebo in the base period and were randomized to the 100 ug group in the extension period, were administered MK-3475 100 ug via oral inhalation for up to 25 months	Extension Period: MK-5475 380 μg Participants who received MK-3475 380 ug in the base period, and participants who received placebo in the base period and were randomized to the 380 ug group in the extension period, were administered MK-3475 380 ug via oral inhalation for up to 25 months
Phase 2 Cohort: Mean Change From Baseline in Cardiac Index (CI) at 12 Weeks	0.1 Liter/minutes/meter square (L/min/m^2) Interval -0.9 to 3.1	0.0 Liter/minutes/meter square (L/min/m^2) Interval -1.7 to 1.4	0.2 Liter/minutes/meter square (L/min/m^2) Interval -1.4 to 1.5	0.1 Liter/minutes/meter square (L/min/m^2) Interval -1.6 to 1.8	—	—	—

SECONDARY outcome

Timeframe: At baseline and 12 weeks

Population: All randomized participants in Phase 2 who received ≥1 dose of study treatment and had baseline observation.

The stroke volume index represents the amount of blood in mL, per square meter of body surface area, that is mobilized with each heart beat. SVI is assessed by RHC. An increase in SVI indicates better right ventricular function and is associated with a reduction of PAH related morbidity and mortality.

Outcome measures

Outcome measures
Measure	Base Period: Placebo n=37 Participants Participants received placebo via oral inhalation once daily for 12 week base period	Base Period: MK-5475 32 µg n=40 Participants Participants received MK-5475 32 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 100 µg n=41 Participants Participants received MK-5475 100 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 380 µg n=41 Participants Participants receive MK-5475 380 µg via oral inhalation once daily for 12 week base period	Extension Period: MK-5475 32 µg Participants who received MK-5475 32 μg in the base period, and those who received matching placebo for MK-5475 32 μg at the end of the base period (12 weeks) were administered MK-5475 32 μg via oral inhalation up to 25 months in the extension period	Extension Period: MK-5475 100 µg Participants who received MK-3475 100 ug in the base period, and participants who received placebo in the base period and were randomized to the 100 ug group in the extension period, were administered MK-3475 100 ug via oral inhalation for up to 25 months	Extension Period: MK-5475 380 μg Participants who received MK-3475 380 ug in the base period, and participants who received placebo in the base period and were randomized to the 380 ug group in the extension period, were administered MK-3475 380 ug via oral inhalation for up to 25 months
Phase 2 Cohort: Mean Change From Baseline in Stroke Volume Index (SVI) at 12 Weeks	2.9 mL/beat/m^2 Interval -9.3 to 44.4	0.2 mL/beat/m^2 Interval -37.2 to 20.7	3.2 mL/beat/m^2 Interval -21.8 to 35.2	1.2 mL/beat/m^2 Interval -29.1 to 25.1	—	—	—

SECONDARY outcome

Timeframe: At baseline and 24 weeks

Population: Phase 3 was not conducted due to the sponsor's decision and thus no data were collected for the outcome measure.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline and 12 weeks

Population: Phase 3 was not conducted due to the sponsor's decision and thus no data were collected for the outcome measure.

The World Health Organization (WHO) classification of functional status is a measure of disease severity, based on a patient's description of their level of functioning and symptoms of disease in relation to their everyday activity. Patients were to be assigned 1 of 4 WHO-FC, dependent on limits of physical activity. As WHO-FC increases from I to IV, limits of physical activity were to increase.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 2.25 years

Population: Analysis population consisted of all randomized participants who received at least one dose of study treatment.

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Outcome measures

Outcome measures
Measure	Base Period: Placebo n=41 Participants Participants received placebo via oral inhalation once daily for 12 week base period	Base Period: MK-5475 32 µg n=42 Participants Participants received MK-5475 32 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 100 µg n=44 Participants Participants received MK-5475 100 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 380 µg n=41 Participants Participants receive MK-5475 380 µg via oral inhalation once daily for 12 week base period	Extension Period: MK-5475 32 µg n=45 Participants Participants who received MK-5475 32 μg in the base period, and those who received matching placebo for MK-5475 32 μg at the end of the base period (12 weeks) were administered MK-5475 32 μg via oral inhalation up to 25 months in the extension period	Extension Period: MK-5475 100 µg n=44 Participants Participants who received MK-3475 100 ug in the base period, and participants who received placebo in the base period and were randomized to the 100 ug group in the extension period, were administered MK-3475 100 ug via oral inhalation for up to 25 months	Extension Period: MK-5475 380 μg n=44 Participants Participants who received MK-3475 380 ug in the base period, and participants who received placebo in the base period and were randomized to the 380 ug group in the extension period, were administered MK-3475 380 ug via oral inhalation for up to 25 months
Phase 2 Cohort: Number of Participants Who Experienced an Adverse Event	27 Participants	28 Participants	28 Participants	27 Participants	33 Participants	38 Participants	39 Participants

SECONDARY outcome

Timeframe: Up to approximately 2.25 years

Population: Analysis population consisted of all randomized participants who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Base Period: Placebo n=41 Participants Participants received placebo via oral inhalation once daily for 12 week base period	Base Period: MK-5475 32 µg n=42 Participants Participants received MK-5475 32 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 100 µg n=44 Participants Participants received MK-5475 100 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 380 µg n=41 Participants Participants receive MK-5475 380 µg via oral inhalation once daily for 12 week base period	Extension Period: MK-5475 32 µg n=45 Participants Participants who received MK-5475 32 μg in the base period, and those who received matching placebo for MK-5475 32 μg at the end of the base period (12 weeks) were administered MK-5475 32 μg via oral inhalation up to 25 months in the extension period	Extension Period: MK-5475 100 µg n=44 Participants Participants who received MK-3475 100 ug in the base period, and participants who received placebo in the base period and were randomized to the 100 ug group in the extension period, were administered MK-3475 100 ug via oral inhalation for up to 25 months	Extension Period: MK-5475 380 μg n=44 Participants Participants who received MK-3475 380 ug in the base period, and participants who received placebo in the base period and were randomized to the 380 ug group in the extension period, were administered MK-3475 380 ug via oral inhalation for up to 25 months
Phase 2 Cohort: Number of Participants Who Discontinued Study Drug Due to an Adverse Event	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to approximately 2.25 years

Population: Phase 3 was not conducted due to the sponsor's decision and thus no data were collected for the outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 2.25 years

Population: Phase 3 was not conducted due to the sponsor's decision and thus no data were collected for the outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

Base Period: Placebo

Serious events: 5 serious events

Other events: 18 other events

Deaths: 2 deaths

Base Period: MK-5475 32 µg

Serious events: 4 serious events

Other events: 22 other events

Deaths: 0 deaths

Base Period: MK-5475 100 µg

Serious events: 3 serious events

Other events: 23 other events

Deaths: 1 deaths

Base Period: MK-5475 380 µg

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

Extension Period: Placebo to MK-5475 32 µg

Serious events: 3 serious events

Other events: 7 other events

Deaths: 1 deaths

Extension Period: Placebo to MK-5475 100 µg

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Extension Period: Placebo to MK-5475 380 µg

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Extension Period: MK-5475 32 µg

Serious events: 5 serious events

Other events: 24 other events

Deaths: 0 deaths

Extension Period: MK-5475 100 µg

Serious events: 4 serious events

Other events: 28 other events

Deaths: 0 deaths

Extension Period: MK-5475 380 μg

Serious events: 11 serious events

Other events: 28 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Base Period: Placebo n=41 participants at risk Participants received placebo via oral inhalation once daily for 12 week base period	Base Period: MK-5475 32 µg n=42 participants at risk Participants received MK-5475 32 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 100 µg n=44 participants at risk Participants received MK-5475 100 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 380 µg n=41 participants at risk Participants received MK-5475 380 µg via oral inhalation once daily for 12 week base period	Extension Period: Placebo to MK-5475 32 µg n=11 participants at risk Participants who received placebo for the during the 12 week base period and were randomized to MK-3475 32 ug for the extension period, received MK-3475 32 ug via oral inhalation once daily for up to 25 months	Extension Period: Placebo to MK-5475 100 µg n=9 participants at risk Participants who received placebo for the during the 12 week base period and were randomized to MK-3475 100 ug for the extension period, received MK-3475 100 ug via oral inhalation once daily for up to 25 months	Extension Period: Placebo to MK-5475 380 µg n=10 participants at risk Participants who received placebo for the during the 12 week base period and were randomized to MK-3475 380 ug for the extension period, received MK-3475 380 ug via oral inhalation once daily for up to 25 months	Extension Period: MK-5475 32 µg n=34 participants at risk Participants who received MK-3475 32 ug during the 12 week base period, received MK-3475 32 ug via oral inhalation once daily for up to 25 months	Extension Period: MK-5475 100 µg n=37 participants at risk Participants who received MK-3475 100 ug during the 12 week base period, received MK-3475 100 ug via oral inhalation once daily for up to 25 months	Extension Period: MK-5475 380 μg n=34 participants at risk Participants who received MK-3475 380 ug during the 12 week base period, received MK-3475 380 ug via oral inhalation once daily for up to 25 months
General disorders Catheter site haemorrhage	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
General disorders Chest pain	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
General disorders Complication associated with device	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Cardiac disorders Atrial flutter	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Cardiac disorders Cardiac failure	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Cardiac disorders Ventricular tachycardia	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Gastrointestinal disorders Pancreatitis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
General disorders Multiple organ dysfunction syndrome	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
General disorders Sudden death	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
General disorders Vascular device occlusion	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations COVID-19	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations COVID-19 pneumonia	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Catheter site infection	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Cellulitis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Device related sepsis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Encephalitis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Erysipelas	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Infection	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Lower respiratory tract infection viral	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.4% 2/37 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Pneumonia mycoplasmal	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Pneumonia viral	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Sepsis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Vascular device infection	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulvovaginal warts	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Nervous system disorders Loss of consciousness	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Nervous system disorders Syncope	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Product Issues Device dislocation	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Product Issues Device leakage	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	18.2% 2/11 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Product Issues Device malfunction	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Psychiatric disorders Delirium	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	4.9% 2/41 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Vascular disorders Aneurysm thrombosis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.

Other adverse events

Other adverse events
Measure	Base Period: Placebo n=41 participants at risk Participants received placebo via oral inhalation once daily for 12 week base period	Base Period: MK-5475 32 µg n=42 participants at risk Participants received MK-5475 32 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 100 µg n=44 participants at risk Participants received MK-5475 100 µg via oral inhalation once daily for 12 week base period	Base Period: MK-5475 380 µg n=41 participants at risk Participants received MK-5475 380 µg via oral inhalation once daily for 12 week base period	Extension Period: Placebo to MK-5475 32 µg n=11 participants at risk Participants who received placebo for the during the 12 week base period and were randomized to MK-3475 32 ug for the extension period, received MK-3475 32 ug via oral inhalation once daily for up to 25 months	Extension Period: Placebo to MK-5475 100 µg n=9 participants at risk Participants who received placebo for the during the 12 week base period and were randomized to MK-3475 100 ug for the extension period, received MK-3475 100 ug via oral inhalation once daily for up to 25 months	Extension Period: Placebo to MK-5475 380 µg n=10 participants at risk Participants who received placebo for the during the 12 week base period and were randomized to MK-3475 380 ug for the extension period, received MK-3475 380 ug via oral inhalation once daily for up to 25 months	Extension Period: MK-5475 32 µg n=34 participants at risk Participants who received MK-3475 32 ug during the 12 week base period, received MK-3475 32 ug via oral inhalation once daily for up to 25 months	Extension Period: MK-5475 100 µg n=37 participants at risk Participants who received MK-3475 100 ug during the 12 week base period, received MK-3475 100 ug via oral inhalation once daily for up to 25 months	Extension Period: MK-5475 380 μg n=34 participants at risk Participants who received MK-3475 380 ug during the 12 week base period, received MK-3475 380 ug via oral inhalation once daily for up to 25 months
General disorders Adverse drug reaction	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
General disorders Chest discomfort	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
General disorders Influenza like illness	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
General disorders Malaise	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
General disorders Oedema peripheral	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	20.0% 2/10 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
General disorders Pain	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.9% 2/41 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
General disorders Peripheral swelling	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
General disorders Pyrexia	4.9% 2/41 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	8.8% 3/34 • Number of events 6 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Hepatobiliary disorders Gallbladder polyp	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
General disorders Chest pain	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.8% 2/42 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
General disorders Fatigue	4.9% 2/41 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	6.8% 3/44 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.8% 4/34 • Number of events 5 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Hepatobiliary disorders Hepatic lesion	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Bronchitis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	8.8% 3/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations COVID-19	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	6.8% 3/44 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	7.3% 3/41 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	30.0% 3/10 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	14.7% 5/34 • Number of events 5 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	16.2% 6/37 • Number of events 6 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	17.6% 6/34 • Number of events 7 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Candida infection	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Erysipelas	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Gastroenteritis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	8.8% 3/34 • Number of events 4 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Bacterial disease carrier	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Onychomycosis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Gastroenteritis viral	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Herpes zoster	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	8.8% 3/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Lower respiratory tract infection	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Nasopharyngitis	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	18.2% 2/11 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	20.0% 2/10 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	13.5% 5/37 • Number of events 5 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Oral candidiasis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	22.2% 2/9 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Periodontitis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Pharyngitis	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.8% 2/42 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Rhinitis	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	8.8% 3/34 • Number of events 4 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Sinusitis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Tooth infection	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Upper respiratory tract infection	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.5% 2/44 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	18.2% 2/11 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	22.2% 2/9 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.8% 4/34 • Number of events 5 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.8% 4/37 • Number of events 6 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.8% 4/34 • Number of events 4 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.8% 4/34 • Number of events 5 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	8.8% 3/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Vascular device infection	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Accidental overdose	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	7.1% 3/42 • Number of events 8 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.5% 2/44 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 7 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	23.5% 8/34 • Number of events 10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.4% 2/37 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	8.8% 3/34 • Number of events 8 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Skin laceration	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Wound haemorrhage	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Investigations Blood creatinine increased	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 4 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.4% 2/37 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Gastrointestinal disorders Portal hypertensive gastropathy	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	7.1% 3/42 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.9% 2/41 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.4% 2/37 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Anaemia	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 4/44 • Number of events 4 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.4% 2/37 • Number of events 6 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Cardiac disorders Palpitations	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.5% 2/44 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.8% 2/42 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.4% 2/37 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Eye disorders Blindness unilateral	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Eye disorders Eye swelling	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.4% 2/37 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.4% 2/37 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	18.2% 2/11 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	7.3% 3/41 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.8% 2/42 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.5% 2/44 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	7.3% 3/41 • Number of events 4 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	22.2% 2/9 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	20.0% 2/10 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Gastrointestinal disorders Erosive duodenitis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Gastrointestinal disorders Gastric polyps	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	6.8% 3/44 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	7.3% 3/41 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	18.2% 2/11 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	20.0% 2/10 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	8.1% 3/37 • Number of events 4 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Investigations Gamma-glutamyltransferase increased	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Investigations N-terminal prohormone brain natriuretic peptide increased	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Investigations Platelet count decreased	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Throat irritation	4.9% 2/41 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.9% 2/41 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Fluid retention	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Folate deficiency	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Iron deficiency	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.4% 2/37 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.5% 2/44 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.8% 4/34 • Number of events 4 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.4% 2/37 • Number of events 6 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	7.1% 3/42 • Number of events 4 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.4% 2/37 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Neck pain	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	20.0% 2/10 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	7.3% 3/41 • Number of events 10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.8% 2/42 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.5% 2/44 • Number of events 4 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	14.7% 5/34 • Number of events 6 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.8% 4/37 • Number of events 5 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Nervous system disorders Headache	9.8% 4/41 • Number of events 4 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	7.1% 3/42 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	18.2% 8/44 • Number of events 8 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	14.6% 6/41 • Number of events 7 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	21.6% 8/37 • Number of events 8 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.8% 4/34 • Number of events 6 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Product Issues Product after taste	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Renal and urinary disorders Proteinuria	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Renal and urinary disorders Renal cyst	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Renal and urinary disorders Renal failure	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Reproductive system and breast disorders Gynaecomastia	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	4.9% 2/41 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.8% 2/42 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.5% 2/44 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	20.0% 2/10 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.8% 4/34 • Number of events 5 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.8% 4/37 • Number of events 4 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	14.7% 5/34 • Number of events 7 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.8% 4/41 • Number of events 6 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.8% 2/42 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	20.0% 2/10 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	17.6% 6/34 • Number of events 7 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.4% 2/37 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.5% 2/44 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	8.8% 3/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	20.0% 2/10 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.9% 2/41 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.5% 2/44 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.9% 2/41 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	4.8% 2/42 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	8.8% 3/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.9% 2/41 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	5.9% 2/34 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	8.8% 3/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Sputum increased	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Vascular disorders Haematoma	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Vascular disorders Hot flush	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/11 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	11.1% 1/9 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.7% 1/37 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Vascular disorders Hypotension	4.9% 2/41 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.3% 1/44 • Number of events 2 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.0% 1/10 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	2.9% 1/34 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	10.8% 4/37 • Number of events 4 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	8.8% 3/34 • Number of events 3 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.
Vascular disorders Venous occlusion	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/42 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/44 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	9.1% 1/11 • Number of events 1 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/9 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/10 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/37 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.	0.00% 0/34 • Up to approximately 37 months All-cause mortality includes all randomized participants and adverse events include all participants who received at least one dose of study treatment.

Additional Information

Senior Vice President, Global Clinical Development

MSD

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER