Trial Outcomes & Findings for A Study of Single Doses of Frespaciguat (MK-5475) on Pulmonary Vascular Resistance (MK-5475-002) (NCT NCT03744637)

NCT ID: NCT03744637

Last Updated: 2025-06-04

Results Overview

An AE was defined as any untoward medical occurrence in a participant which may not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease that was temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The number of participants who experienced at least 1 AE was reported by dose separately for Part 1 plus Part 2 Period 1, for the RHC Period, and for the FRI Period.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 25 participants
• Primary outcome timeframe: Up to ~14 days after last dose of treatment period (Up to ~32 weeks total)
• Results posted on: 2025-06-04

Participant Flow

Adult participants with Group 1 Pulmonary Arterial Hypertension (PAH) were recruited to evaluate safety, pharmacokinetics (PK), Functional Respiratory Imaging (FRI), and Right Heart Catheterization (RHC) of single-dose MK-5475.

Participant milestones

Measure	MK-5475 120 ug/MK-5475 165 ug/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A) Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).	MK-5475 120 ug/Placebo/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A) Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), placebo (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).	MK-5475 120 ug/MK-5475 165 ug/Placebo/MK-5475 240 ug/MK-5475 240 ug (Panel A) Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), placebo (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).	Placebo/MK-5475 165 ug/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A) Participant received inhaled doses as follows: placebo (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), 240 ug (Part 2 Period 2), and 240 ug (Part 2 Period 3).	Placebo/MK-5475 165 ug/MK-5475 240 ug (Panel A) Participant received inhaled doses as follows: placebo (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), and 240 ug (Part 1 Period 3).	MK-5475 300 ug/ MK-5475 165 ug/ MK-5475 165 ug (Panel B) Participant received inhaled doses as follows: MK-5475 300 ug (Part 2 Period 1), MK-5475 165 ug (Part 2 Period 2), and 165 ug (Part 2 Period 3).	MK-5475 300 ug/ MK-5475 360 ug/ MK-5475 360 ug (Panels B+C) Participants received inhaled doses as follows: MK-5475 300 ug (Part 2 Period 1), MK-5475 360 ug (Part 2 Period 2), and 360 ug (Part 2 Period 3).	MK-5475 300 ug/ MK-5475 120 ug/ MK-5475 120 ug (Panel C) Participants received inhaled doses as follows: MK-5475 300 ug (Part 2 Period 1), MK-5475 120 ug (Part 2 Period 2), and 120 ug (Part 2 Period 3).	MK-5475 480 ug/ MK-5475 120 ug/ MK-5475 120 ug (Panel D) Participants received inhaled doses as follows: MK-5475 480 ug (Part 2 Period 1), MK-5475 120 ug (Part 2 Period 2), and 120 ug (Part 2 Period 3).	MK-5475 480 ug/ MK-5475 120 ug (Panel D) Participant received inhaled doses as follows: MK-5475 480 ug (Part 2 Period 1) and MK-5475 120 ug (Part 2 Period 2).
Overall Study STARTED	2	2	2	1	1	1	8	4	3	1
Overall Study COMPLETED	2	2	2	1	1	1	8	4	3	1
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Single Doses of Frespaciguat (MK-5475) on Pulmonary Vascular Resistance (MK-5475-002)

Baseline characteristics by cohort

Measure	MK-5475 120 ug/MK-5475 165 ug/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A) n=2 Participants Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).	MK-5475 120 ug/Placebo/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A) n=2 Participants Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), placebo (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).	MK-5475 120 ug/MK-5475 165 ug/Placebo/MK-5475 240 ug/MK-5475 240 ug (Panel A) n=2 Participants Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), placebo (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).	Placebo/MK-5475 165 ug/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A) n=1 Participants Participant received inhaled doses as follows: placebo (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), 240 ug (Part 2 Period 2), and 240 ug (Part 2 Period 3).	Placebo/MK-5475 165 ug/MK-5475 240 ug (Panel A) n=1 Participants Participant received inhaled doses as follows: placebo (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), and 240 ug (Part 1 Period 3).	MK-5475 300 ug/ MK-5475 165 ug/ MK-5475 165 ug (Panel B) n=1 Participants Participant received inhaled doses as follows: MK-5475 300 ug (Part 2 Period 1), MK-5475 165 ug (Part 2 Period 2), and 165 ug (Part 2 Period 3).	MK-5475 300 ug/ MK-5475 360 ug/ MK-5475 360 ug (Panels B+C) n=8 Participants Participants received inhaled doses as follows: MK-5475 300 ug (Part 2 Period 1), MK-5475 360 ug (Part 2 Period 2), and 360 ug (Part 2 Period 3).	MK-5475 300 ug/ MK-5475 120 ug/ MK-5475 120 ug (Panel C) n=4 Participants Participants received inhaled doses as follows: MK-5475 300 ug (Part 2 Period 1), MK-5475 120 ug (Part 2 Period 2), and 120 ug (Part 2 Period 3).	MK-5475 480 ug/ MK-5475 120 ug/ MK-5475 120 ug (Panel D) n=3 Participants Participants received inhaled doses as follows: MK-5475 480 ug (Part 2 Period 1), MK-5475 120 ug (Part 2 Period 2), and 120 ug (Part 2 Period 3).	MK-5475 480 ug/ MK-5475 120 ug (Panel D) n=1 Participants Participant received inhaled doses as follows: MK-5475 480 ug (Part 2 Period 1) and MK-5475 120 ug (Part 2 Period 2).	Total n=25 Participants Total of all reporting groups
Age, Continuous	53.0 Years STANDARD_DEVIATION 1.4 • n=5 Participants	51.0 Years STANDARD_DEVIATION 4.2 • n=7 Participants	61.0 Years STANDARD_DEVIATION 4.2 • n=5 Participants	61.0 Years STANDARD_DEVIATION NA • n=4 Participants	61.0 Years STANDARD_DEVIATION NA • n=21 Participants	52.0 Years STANDARD_DEVIATION NA • n=10 Participants	48.6 Years STANDARD_DEVIATION 14.4 • n=115 Participants	61.3 Years STANDARD_DEVIATION 2.2 • n=24 Participants	62.7 Years STANDARD_DEVIATION 5.9 • n=42 Participants	69.0 Years STANDARD_DEVIATION NA • n=42 Participants	55.8 Years STANDARD_DEVIATION 10.4 • n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	6 Participants n=115 Participants	3 Participants n=24 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	18 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	7 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	8 Participants n=115 Participants	4 Participants n=24 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	25 Participants n=42 Participants
Ethnicity (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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	8 Participants n=115 Participants	4 Participants n=24 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	25 Participants n=42 Participants
Race (NIH/OMB) More than one race	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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to ~14 days after last dose of treatment period (Up to ~32 weeks total)

Population: All participants who received ≥1 dose of investigational treatment were analyzed according to treatment received.

An AE was defined as any untoward medical occurrence in a participant which may not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease that was temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The number of participants who experienced at least 1 AE was reported by dose separately for Part 1 plus Part 2 Period 1, for the RHC Period, and for the FRI Period.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) n=13 Participants Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) n=4 Participants Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) n=6 Participants Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 n=7 Participants Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) n=1 Participants Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=7 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=8 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=8 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) n=1 Participants Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) n=7 Participants Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) n=8 Participants Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) Participants in Panel C received MK-5475 360 ug during the FRI Period.
Number of Participants Who Experienced at Least 1 Adverse Event (AE): All Parts	2 Participants	1 Participants	3 Participants	5 Participants	2 Participants	4 Participants	5 Participants	1 Participants	6 Participants	4 Participants	1 Participants	0 Participants	0 Participants	4 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to ~14 days after last dose of treatment period (Up to ~32 weeks total)

Population: All participants who received ≥1 dose of investigational treatment were analyzed according to treatment received.

An AE was defined as any untoward medical occurrence in a participant which may not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease that was temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The number of participants who discontinued from the study due to an AE was reported by dose separately for Part 1 plus Part 2 Period 1, for the RHC Period, and for the FRI Period.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) n=13 Participants Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) n=4 Participants Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) n=6 Participants Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 n=7 Participants Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) n=1 Participants Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=7 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=8 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=8 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) n=1 Participants Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) n=7 Participants Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) n=8 Participants Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) Participants in Panel C received MK-5475 360 ug during the FRI Period.
Number of Participants Who Discontinued From the Study Due to an AE: All Parts	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and up to 4.5 hours post-dose

Population: All participants who received ≥1 dose of MK-5475, who complied with the protocol without major protocol deviations, and who underwent the RHC procedure and had available data were analyzed according to treatment received.

For each participant in the RHC Period, the percentage change from baseline for the minimum post-dose PVR value over the duration of the RHC procedure was calculated. The average of pre-dose measurements was set as the baseline. Mean (SD) percent change from baseline in PVR minimum were calculated and reported for each dose group that underwent RHC in Part 2. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 n=7 Participants Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) n=1 Participants Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=7 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=8 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) Participants in Panel C received MK-5475 360 ug during the FRI Period.
Percentage Change From Baseline in Minimum Pulmonary Vascular Resistance (PVR): Part 2 Right Heart Catheterization (RHC) Period	—	—	—	—	—	—	-20.77 Percentage change Standard Deviation 13.88	13.01 Percentage change Standard Deviation NA NA = Standard Deviation not reported when n\<2.	-29.46 Percentage change Standard Deviation 13.72	-29.25 Percentage change Standard Deviation 17.58	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 0.5 hours post-dose

Population: All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.

HR was assessed at pre-dose in the RHC Period (baseline) and at 0.5 hours post-dose. Baseline HR and change from baseline in HR was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in HR. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 n=4 Participants Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=7 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=4 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=9 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) Participants in Panel C received MK-5475 360 ug during the FRI Period.
Change From Baseline in Heart Rate (HR) at 0.5 Hours Post-dose: Part 2 RHC Period Baseline HR	—	—	—	—	—	—	74.75 beats/minute Standard Error 9.78	—	62.57 beats/minute Standard Error 6.23	68.75 beats/minute Standard Error 2.36	69.06 beats/minute Standard Error 4.29	—	—	—	—	—	—	—	—
Change From Baseline in Heart Rate (HR) at 0.5 Hours Post-dose: Part 2 RHC Period Change from Baseline in HR	—	—	—	—	—	—	3.56 beats/minute Standard Error 7.60	—	1.83 beats/minute Standard Error 1.56	4.92 beats/minute Standard Error 3.03	-2.76 beats/minute Standard Error 1.60	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 4.5 hours post-dose

Population: All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.

HR was assessed at pre-dose in the RHC Period (baseline) and at 4.5 hours post-dose. Baseline HR and change from baseline in HR was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in HR. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 n=4 Participants Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=7 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=4 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=9 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) Participants in Panel C received MK-5475 360 ug during the FRI Period.
Change From Baseline in Heart Rate (HR) at 4.5 Hours Post-dose: Part 2 RHC Period Baseline HR	—	—	—	—	—	—	74.75 beats/minute Standard Error 9.78	—	62.57 beats/minute Standard Error 6.23	68.75 beats/minute Standard Error 2.36	69.06 beats/minute Standard Error 4.29	—	—	—	—	—	—	—	—
Change From Baseline in Heart Rate (HR) at 4.5 Hours Post-dose: Part 2 RHC Period Change from Baseline in HR	—	—	—	—	—	—	-0.56 beats/minute Standard Error 4.55	—	3.20 beats/minute Standard Error 3.51	7.17 beats/minute Standard Error 1.55	-0.98 beats/minute Standard Error 2.01	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 24 hours post-dose

Population: All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.

HR was assessed at pre-dose in the RHC Period (baseline) and at 24 hours post-dose. Baseline HR and change from baseline in HR was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in HR. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 n=4 Participants Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=7 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=4 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=9 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) Participants in Panel C received MK-5475 360 ug during the FRI Period.
Change From Baseline in Heart Rate (HR) at 24 Hours Post-dose: Part 2 RHC Period Baseline HR	—	—	—	—	—	—	74.75 beats/minute Standard Error 9.78	—	62.57 beats/minute Standard Error 6.23	68.75 beats/minute Standard Error 2.36	69.06 beats/minute Standard Error 4.29	—	—	—	—	—	—	—	—
Change From Baseline in Heart Rate (HR) at 24 Hours Post-dose: Part 2 RHC Period Change from Baseline in HR	—	—	—	—	—	—	1.78 beats/minute Standard Error 7.35	—	7.43 beats/minute Standard Error 3.32	2.42 beats/minute Standard Error 3.10	-0.72 beats/minute Standard Error 2.53	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 0.5 hours post-dose

Population: All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.

SBP was assessed at pre-dose in the RHC Period (baseline) and at 0.5 hours post-dose. Baseline SBP and change from baseline in SBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in SBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 n=4 Participants Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=7 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=4 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=9 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) Participants in Panel C received MK-5475 360 ug during the FRI Period.
Change From Baseline in Systolic Blood Pressure (SBP) at 0.5 Hours Post-dose: Part 2 RHC Period Baseline SBP	—	—	—	—	—	—	123.25 Millimeters of mercury (mmHg) Standard Error 9.80	—	132.86 Millimeters of mercury (mmHg) Standard Error 3.79	128.50 Millimeters of mercury (mmHg) Standard Error 9.65	119.11 Millimeters of mercury (mmHg) Standard Error 4.72	—	—	—	—	—	—	—	—
Change From Baseline in Systolic Blood Pressure (SBP) at 0.5 Hours Post-dose: Part 2 RHC Period Change from Baseline in SBP	—	—	—	—	—	—	25.33 Millimeters of mercury (mmHg) Standard Error 2.52	—	2.67 Millimeters of mercury (mmHg) Standard Error 3.70	-1.17 Millimeters of mercury (mmHg) Standard Error 3.46	5.30 Millimeters of mercury (mmHg) Standard Error 2.36	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 4.5 hours post-dose

Population: All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.

SBP was assessed at pre-dose in the RHC Period (baseline) and at 4.5 hours post-dose. Baseline SBP and change from baseline in SBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in SBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 n=4 Participants Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=7 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=4 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=9 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) Participants in Panel C received MK-5475 360 ug during the FRI Period.
Change From Baseline in Systolic Blood Pressure (SBP) at 4.5 Hours Post-dose: Part 2 RHC Period Baseline SBP	—	—	—	—	—	—	123.25 Millimeters of mercury (mmHg) Standard Error 9.80	—	132.86 Millimeters of mercury (mmHg) Standard Error 3.79	128.50 Millimeters of mercury (mmHg) Standard Error 9.65	119.11 Millimeters of mercury (mmHg) Standard Error 4.72	—	—	—	—	—	—	—	—
Change From Baseline in Systolic Blood Pressure (SBP) at 4.5 Hours Post-dose: Part 2 RHC Period Change from Baseline in SBP	—	—	—	—	—	—	10.67 Millimeters of mercury (mmHg) Standard Error 0.38	—	4.93 Millimeters of mercury (mmHg) Standard Error 5.65	7.50 Millimeters of mercury (mmHg) Standard Error 1.55	11.96 Millimeters of mercury (mmHg) Standard Error 6.31	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 24 hours post-dose

Population: All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.

SBP was assessed at pre-dose in the RHC Period (baseline) and at 24 hours post-dose. Baseline SBP and change from baseline in SBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in SBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 n=4 Participants Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=7 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=4 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=9 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) Participants in Panel C received MK-5475 360 ug during the FRI Period.
Change From Baseline in Systolic Blood Pressure (SBP) at 24 Hours Post-dose: Part 2 RHC Period Baseline SBP	—	—	—	—	—	—	123.25 Millimeters of mercury (mmHg) Standard Error 9.80	—	132.86 Millimeters of mercury (mmHg) Standard Error 3.79	128.50 Millimeters of mercury (mmHg) Standard Error 9.65	119.11 Millimeters of mercury (mmHg) Standard Error 4.72	—	—	—	—	—	—	—	—
Change From Baseline in Systolic Blood Pressure (SBP) at 24 Hours Post-dose: Part 2 RHC Period Change from Baseline in SBP	—	—	—	—	—	—	6.22 Millimeters of mercury (mmHg) Standard Error 5.28	—	-5.95 Millimeters of mercury (mmHg) Standard Error 5.78	2.25 Millimeters of mercury (mmHg) Standard Error 7.62	0.74 Millimeters of mercury (mmHg) Standard Error 3.44	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 0.5 hours post-dose

Population: All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.

DBP was assessed at pre-dose in the RHC Period (baseline) and at 0.5 hours post-dose. Baseline DBP and change from baseline in DBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in DBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 n=4 Participants Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=7 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=4 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=9 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) Participants in Panel C received MK-5475 360 ug during the FRI Period.
Change From Baseline in Diastolic Blood Pressure (DBP) at 0.5 Hours Post-dose: Part 2 RHC Period Baseline DBP	—	—	—	—	—	—	69.75 Millimeters of mercury (mmHg) Standard Error 4.03	—	72.43 Millimeters of mercury (mmHg) Standard Error 2.25	77.00 Millimeters of mercury (mmHg) Standard Error 4.95	70.78 Millimeters of mercury (mmHg) Standard Error 3.52	—	—	—	—	—	—	—	—
Change From Baseline in Diastolic Blood Pressure (DBP) at 0.5 Hours Post-dose: Part 2 RHC Period Change from Baseline in DBP	—	—	—	—	—	—	4.00 Millimeters of mercury (mmHg) Standard Error 4.60	—	0.94 Millimeters of mercury (mmHg) Standard Error 1.68	0.75 Millimeters of mercury (mmHg) Standard Error 3.48	1.30 Millimeters of mercury (mmHg) Standard Error 1.75	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 4.5 hours post-dose

Population: All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.

DBP was assessed at pre-dose in the RHC Period (baseline) and at 4.5 hours post-dose. Baseline DBP and change from baseline in DBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in DBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 n=4 Participants Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=7 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=4 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=9 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) Participants in Panel C received MK-5475 360 ug during the FRI Period.
Change From Baseline in Diastolic Blood Pressure (DBP) at 4.5 Hours Post-dose: Part 2 RHC Period Baseline DBP	—	—	—	—	—	—	69.75 Millimeters of mercury (mmHg) Standard Error 4.03	—	72.43 Millimeters of mercury (mmHg) Standard Error 2.25	77.00 Millimeters of mercury (mmHg) Standard Error 4.95	70.78 Millimeters of mercury (mmHg) Standard Error 3.52	—	—	—	—	—	—	—	—
Change From Baseline in Diastolic Blood Pressure (DBP) at 4.5 Hours Post-dose: Part 2 RHC Period Change from Baseline in DBP	—	—	—	—	—	—	-0.22 Millimeters of mercury (mmHg) Standard Error 4.87	—	1.07 Millimeters of mercury (mmHg) Standard Error 2.34	3.58 Millimeters of mercury (mmHg) Standard Error 2.73	4.00 Millimeters of mercury (mmHg) Standard Error 4.28	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 24 hours post-dose

Population: All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.

DBP was assessed at pre-dose in the RHC Period (baseline) and at 24 hours post-dose. Baseline DBP and change from baseline in DBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in DBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 n=4 Participants Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=7 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=4 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=9 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) Participants in Panel C received MK-5475 360 ug during the FRI Period.
Change From Baseline in Diastolic Blood Pressure (DBP) at 24 Hours Post-dose: Part 2 RHC Period Baseline SBP	—	—	—	—	—	—	69.75 Millimeters of mercury (mmHg) Standard Error 4.03	—	72.43 Millimeters of mercury (mmHg) Standard Error 2.25	77.00 Millimeters of mercury (mmHg) Standard Error 4.95	70.78 Millimeters of mercury (mmHg) Standard Error 3.52	—	—	—	—	—	—	—	—
Change From Baseline in Diastolic Blood Pressure (DBP) at 24 Hours Post-dose: Part 2 RHC Period Change from Baseline in SBP	—	—	—	—	—	—	-1.44 Millimeters of mercury (mmHg) Standard Error 0.89	—	-2.76 Millimeters of mercury (mmHg) Standard Error 3.22	2.42 Millimeters of mercury (mmHg) Standard Error 3.15	-1.74 Millimeters of mercury (mmHg) Standard Error 2.89	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1 and Part 2 Period 1: Predose and 0.1, 0.25, 0.5, 1, 2, 3, 4, 8, and 24 hours post-dose; RHC Period: predose and 0.25, 0.5, 1, 2, 3, 4, and 4.5 hours; FRI Period: predose and 1, 3, 8, and 24 hours postdose (Panel D also 0.25, 0.5, 2, 4 hours)

Population: All participants who received at least one dose of MK-5475, who complied with the protocol without major protocol deviations, and who had available data for AUC0-inf were analyzed. Per protocol, data from participants receiving placebo were not included in the analysis.

Blood samples were taken at predose and at specified time points postdose to determine the AUC0-inf of MK-5475. AUC0-inf was defined as the area under the concentration-time curve of MK-5475 from time zero to infinity. MK-5475 AUC0-inf was reported by panel/dose group. Per protocol, percent geometric coefficient of variation (%GCV) values were not reported for groups with n<2 participants.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) n=2 Participants Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) n=5 Participants Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) n=4 Participants Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) n=9 Participants Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) n=4 Participants Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) n=4 Participants Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=3 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=6 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) n=3 Participants Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) n=5 Participants Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) n=3 Participants Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) n=4 Participants Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) n=1 Participants Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) n=4 Participants Participants in Panel C received MK-5475 360 ug during the FRI Period.
Area Under the Concentration-Time Curve From Hour 0 to Infinity (AUC0-inf) of MK-5475: All Parts	1.00 nM*hr Geometric Coefficient of Variation 45.5	0.721 nM*hr Geometric Coefficient of Variation 103.6	1.25 nM*hr Geometric Coefficient of Variation 59.7	2.15 nM*hr Geometric Coefficient of Variation 106.3	1.66 nM*hr Geometric Coefficient of Variation 66.8	4.59 nM*hr Geometric Coefficient of Variation 20.9	—	1.03 nM*hr Geometric Coefficient of Variation 20.0	1.05 nM*hr Geometric Coefficient of Variation 28.9	—	1.03 nM*hr Geometric Coefficient of Variation 59.7	1.46 nM*hr Geometric Coefficient of Variation 63.2	3.46 nM*hr Geometric Coefficient of Variation 67.3	0.748 nM*hr Geometric Coefficient of Variation 43.9	0.978 nM*hr Geometric Coefficient of Variation 18.3	4.26 nM*hr Geometric Coefficient of Variation NA NA = %GCV values were not reported when n\<2	—	—	4.10 nM*hr Geometric Coefficient of Variation 37.6

SECONDARY outcome

Timeframe: Part 1 and Part 2 Period 1: Predose and 0.1, 0.25, 0.5, 1, 2, 3, 4, 8, and 24 hours post-dose; RHC Period: predose and 0.25, 0.5, 1, 2, 3, 4, and 4.5 hours; FRI Period: predose and 1, 3, 8, and 24 hours postdose (Panel D also 0.25, 0.5, 2, 4 hours)

Population: All participants who received at least one dose of MK-5475, who complied with the protocol without major protocol deviations, and who had available data for AUC0-24hr were analyzed. Per protocol, data from participants receiving placebo were not included in the analysis.

Blood samples were taken at predose and at specified time points postdose to determine the AUC0-24hr of MK-5475. AUC0-24hr was defined as the area under the concentration-time curve of MK-5475 from time zero to 24 hours. MK-5475 AUC0-24hr was reported by panel/dose group. For RHC panel/dose groups where sampling was only done up to 4.5 hours, the AUC0-24hr geometric mean represents an extrapolated AUC0-24hr value. Per protocol, %GCV values were not reported for groups with n<2 participants.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) n=4 Participants Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) n=9 Participants Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) n=4 Participants Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) n=4 Participants Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=4 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=1 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=7 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) n=3 Participants Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) n=5 Participants Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) n=4 Participants Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) n=4 Participants Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) n=1 Participants Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) n=7 Participants Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) n=3 Participants Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) n=5 Participants Participants in Panel C received MK-5475 360 ug during the FRI Period.
Area Under the Concentration-Time Curve From Hour 0 to 24 Hours (AUC0-24hr) of MK-5475: All Parts	0.259 nM*hr Geometric Coefficient of Variation 288.2	0.613 nM*hr Geometric Coefficient of Variation 136.0	1.42 nM*hr Geometric Coefficient of Variation 59.9	2.35 nM*hr Geometric Coefficient of Variation 96.2	1.82 nM*hr Geometric Coefficient of Variation 63.2	4.53 nM*hr Geometric Coefficient of Variation 21.0	—	1.02 nM*hr Geometric Coefficient of Variation 18.5	1.05 nM*hr Geometric Coefficient of Variation 28.9	NA nM*hr Geometric Coefficient of Variation NA NA = Not calculated due to insufficient samples on the terminal phase to estimate lambda z	1.04 nM*hr Geometric Coefficient of Variation 59.0	1.45 nM*hr Geometric Coefficient of Variation 61.7	3.48 nM*hr Geometric Coefficient of Variation 68.3	0.747 nM*hr Geometric Coefficient of Variation 43.5	1.13 nM*hr Geometric Coefficient of Variation 18.4	4.19 nM*hr Geometric Coefficient of Variation NA NA = %GCV values were not reported when n\<2	1.71 nM*hr Geometric Coefficient of Variation 43.3	1.21 nM*hr Geometric Coefficient of Variation 80.1	3.82 nM*hr Geometric Coefficient of Variation 35.3

SECONDARY outcome

Timeframe: Part 1 and Part 2 Period 1: Predose and 0.1, 0.25, 0.5, 1, 2, 3, 4, 8, and 24 hours post-dose; RHC Period: predose and 0.25, 0.5, 1, 2, 3, 4, and 4.5 hours; FRI Period: predose and 1, 3, 8, and 24 hours postdose (Panel D also 0.25, 0.5, 2, 4 hours)

Population: All participants who received at least one dose of MK-5475, who complied with the protocol without major protocol deviations, and who had available data for Cmax were analyzed. Per protocol, data from participants receiving placebo were not included in the analysis.

Blood samples were taken at predose and at specified time points postdose to determine the Cmax of MK-5475. Cmax was defined as the maximum concentration of MK-5475 reached. MK-5475 Cmax was reported by panel/dose group. Per protocol, %GCV values were not reported for groups with n<2 participants.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) n=4 Participants Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) n=9 Participants Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) n=4 Participants Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) n=4 Participants Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=4 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=1 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=7 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) n=3 Participants Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) n=5 Participants Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) n=4 Participants Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) n=4 Participants Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) n=1 Participants Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) n=7 Participants Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) n=3 Participants Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) n=5 Participants Participants in Panel C received MK-5475 360 ug during the FRI Period.
Maximum Concentration (Cmax) of MK-5475: All Parts	0.0722 nM Geometric Coefficient of Variation 153.3	0.139 nM Geometric Coefficient of Variation 117.9	0.297 nM Geometric Coefficient of Variation 60.8	0.543 nM Geometric Coefficient of Variation 73.9	0.409 nM Geometric Coefficient of Variation 66.0	0.981 nM Geometric Coefficient of Variation 22.9	—	0.218 nM Geometric Coefficient of Variation 4.7	0.161 nM Geometric Coefficient of Variation 76.5	0.312 nM Geometric Coefficient of Variation NA NA = %GCV values were not reported when n\<2	0.202 nM Geometric Coefficient of Variation 59.7	0.307 nM Geometric Coefficient of Variation 21.7	0.960 nM Geometric Coefficient of Variation 67.9	0.228 nM Geometric Coefficient of Variation 36.8	0.245 nM Geometric Coefficient of Variation 21.7	0.601 nM Geometric Coefficient of Variation NA NA = %GCV values were not reported when n\<2	0.341 nM Geometric Coefficient of Variation 40.1	0.301 nM Geometric Coefficient of Variation 69.8	0.915 nM Geometric Coefficient of Variation 56.5

SECONDARY outcome

Timeframe: 24 hours postdose

Population: All participants who received at least one dose of MK-5475, who complied with the protocol without major protocol deviations, and who had available data for C24 were analyzed. Per protocol, data from participants receiving placebo were not included in the analysis.

Blood samples were taken at predose and at specified time points postdose to determine the C24 of MK-5475. C24 was defined as the concentration of MK-5475 reached at 24 hours. MK-5475 Cmax was reported by panel/dose group. Per protocol, %GCV values were not reported for groups with n<2 participants.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) n=4 Participants Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) n=9 Participants Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) n=4 Participants Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) n=4 Participants Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=4 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=1 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=7 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) n=3 Participants Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) n=5 Participants Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) n=4 Participants Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) n=4 Participants Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) n=1 Participants Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) n=7 Participants Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) n=3 Participants Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) n=5 Participants Participants in Panel C received MK-5475 360 ug during the FRI Period.
Concentration of MK-5475 at 24 Hours Postdose (C24): All Parts	NA nM Geometric Coefficient of Variation NA NA= no participant had detectable C24	NA nM Geometric Coefficient of Variation NA NA= no participant had detectable C24	NA nM Geometric Coefficient of Variation NA NA= no participant had detectable C24	NA nM Geometric Coefficient of Variation NA NA= no participant had detectable C24	NA nM Geometric Coefficient of Variation NA NA= no participant had detectable C24	0.0113 nM Geometric Coefficient of Variation 25.0	—	NA nM Geometric Coefficient of Variation NA NA = C24 could not be calculated since PK samples were only collected up to 4.5 hours in the RHC Period	NA nM Geometric Coefficient of Variation NA NA = C24 could not be calculated since PK samples were only collected up to 4.5 hours in the RHC Period	NA nM Geometric Coefficient of Variation NA NA = C24 could not be calculated since PK samples were only collected up to 4.5 hours in the RHC Period	NA nM Geometric Coefficient of Variation NA NA = C24 could not be calculated since PK samples were only collected up to 4.5 hours in the RHC Period	NA nM Geometric Coefficient of Variation NA NA = C24 could not be calculated since PK samples were only collected up to 4.5 hours in the RHC Period	NA nM Geometric Coefficient of Variation NA NA = C24 could not be calculated since PK samples were only collected up to 4.5 hours in the RHC Period	NA nM Geometric Coefficient of Variation NA NA= no participant had detectable C24	NA nM Geometric Coefficient of Variation NA NA= no participant had detectable C24	0.0128 nM Geometric Coefficient of Variation NA NA = %GCV values were not reported when n\<2	NA nM Geometric Coefficient of Variation NA NA = C24 could not be calculated due to an insufficient number of participants with detectable C24 to calculate geometric mean (%GCV)	NA nM Geometric Coefficient of Variation NA NA= no participant had detectable C24	NA nM Geometric Coefficient of Variation NA NA = C24 could not be calculated due to an insufficient number of participants with detectable C24 to calculate geometric mean (%GCV)

SECONDARY outcome

Timeframe: Part 1 and Part 2 Period 1: Predose and 0.1, 0.25, 0.5, 1, 2, 3, 4, 8, and 24 hours post-dose; RHC Period: predose and 0.25, 0.5, 1, 2, 3, 4, and 4.5 hours; FRI Period: predose and 1, 3, 8, and 24 hours postdose (Panel D also 0.25, 0.5, 2, 4 hours)

Population: All participants who received at least one dose of MK-5475, who complied with the protocol without major protocol deviations, and who had available data for Tmax were analyzed. Per protocol, data from participants receiving placebo were not included in the analysis.

Blood samples were taken at predose and at specified time points postdose to determine the Tmax of MK-5475. Tmax was defined as the time to maximum concentration of MK-5475. MK-5475 Tmax was reported by panel/dose group.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) n=4 Participants Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) n=9 Participants Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) n=4 Participants Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) n=4 Participants Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=4 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=1 Participants Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=7 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) n=3 Participants Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) n=5 Participants Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) n=4 Participants Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) n=4 Participants Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) n=1 Participants Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) n=7 Participants Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) n=3 Participants Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) n=5 Participants Participants in Panel C received MK-5475 360 ug during the FRI Period.
Time to Maximum Concentration (Tmax) of MK-5475: All Parts	2.00 Hour Interval 2.0 to 2.0	1.00 Hour Interval 1.0 to 2.0	2.00 Hour Interval 1.0 to 2.0	1.50 Hour Interval 1.0 to 2.0	1.00 Hour Interval 1.0 to 2.0	1.00 Hour Interval 1.0 to 2.0	—	1.00 Hour Interval 0.5 to 1.0	1.00 Hour Interval 0.0 to 1.0	3.00 Hour Interval 3.0 to 3.0	2.00 Hour Interval 1.0 to 3.0	1.00 Hour Interval 1.0 to 1.0	1.00 Hour Interval 0.5 to 1.0	1.00 Hour Interval 1.0 to 3.0	1.50 Hour Interval 1.0 to 2.0	1.00 Hour Interval 1.0 to 1.0	1.00 Hour Interval 1.0 to 3.0	1.00 Hour Interval 1.0 to 3.0	1.00 Hour Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: Part 1 and Part 2 Period 1: Predose and 0.1, 0.25, 0.5, 1, 2, 3, 4, 8, and 24 hours post-dose; RHC Period: predose and 0.25, 0.5, 1, 2, 3, 4, and 4.5 hours; FRI Period: predose and 1, 3, 8, and 24 hours postdose (Panel D also 0.25, 0.5, 2, 4 hours)

Population: All participants who received at least one dose of MK-5475, who complied with the protocol without major protocol deviations, and who had available data for t½ were analyzed. Per protocol, data from participants receiving placebo were not included in the analysis.

Blood samples were taken at predose and at specified time points postdose to determine the t½ of MK-5475. t½ was defined as the time required to divide the MK-5475 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-5475. MK-5475 t½ was reported by panel/dose group.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) n=2 Participants Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) n=5 Participants Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) n=6 Participants Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) n=4 Participants Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) n=9 Participants Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) n=4 Participants Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) n=4 Participants Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) n=3 Participants Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=6 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) n=3 Participants Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) n=5 Participants Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) n=3 Participants Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) n=4 Participants Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) n=1 Participants Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) n=4 Participants Participants in Panel C received MK-5475 360 ug during the FRI Period.
Apparent Terminal Half-life (t1/2) of MK-5475: All Parts	1.73 Hour Geometric Coefficient of Variation 11.4	1.76 Hour Geometric Coefficient of Variation 10.9	1.87 Hour Geometric Coefficient of Variation 13.5	2.12 Hour Geometric Coefficient of Variation 37.2	2.18 Hour Geometric Coefficient of Variation 37.9	3.67 Hour Geometric Coefficient of Variation 6.6	—	2.82 Hour Geometric Coefficient of Variation 10.5	2.32 Hour Geometric Coefficient of Variation 21.0	—	2.35 Hour Geometric Coefficient of Variation 9.2	3.13 Hour Geometric Coefficient of Variation 45.5	2.05 Hour Geometric Coefficient of Variation 11.6	2.45 Hour Geometric Coefficient of Variation 24.6	2.19 Hour Geometric Coefficient of Variation 8.1	3.89 Hour Geometric Coefficient of Variation NA NA = %GCV values were not reported when n\<2	—	—	3.92 Hour Geometric Coefficient of Variation 7.9

SECONDARY outcome

Timeframe: Baseline: Pre-dose on Day 1 of FRI Period (up to 227 days) and 1, 3, 8, and 24 hours post-dose

Population: All participants who received MK-5475 at 120, 240 or 360 ug during the FRI period and underwent CT scans with IV contrast agent at all time points were included in the analysis.

Participants underwent a series of computed tomography (CT) scans with an intravenous (IV) iodinated contrast agent to facilitate assessment of PBV at baseline and at several times points after MK-5475 dosing. Percentage change from baseline (CFB) in PBV was calculated and reported for each dose group that underwent FRI in Part 2. As pre-specified, central tendency for PBV percentage CFB was provided as numerical values rounded to whole numbers. Per protocol, this outcome measure was only assessed during the Part 2 FRI Period for each panel and was not assessed during Part 1.

Outcome measures

Measure	MK-5475 120 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) Participants in Panel A received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panel B) Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.	MK-5475 300 ug: Part 2 Period 1 (Panel C) Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel C) Participants in Panel C received MK-5475 120 ug during the RHC Period.	MK-5475 120 ug: RHC (Panel D) Participants in Panel D received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) Participant in Panel B received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=8 Participants Participants in Panel A received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel B) Participants in Panel B received MK-5475 360 ug during the RHC Period.	MK-5475 360 ug: RHC (Panel C) n=6 Participants Participants in Panel C received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panel C) n=7 Participants Participants in Panel C received MK-5475 120 ug during the FRI Period.	MK-5475 120 ug: FRI (Panel D) Participants in Panel D received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) Participant in Panel B received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) Participants in Panel A received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel B) Participants in Panel B received MK-5475 360 ug during the FRI Period.	MK-5475 360 ug: FRI (Panel C) Participants in Panel C received MK-5475 360 ug during the FRI Period.
Percentage Change From Baseline in Pulmonary Blood Volume (PBV) Over Time: Part 2 Functional Respiratory Imaging (FRI) Period CFB at 1 hour	—	—	—	—	—	—	—	—	—	—	-2 Percentage change	—	2 Percentage change	3 Percentage change	—	—	—	—	—
Percentage Change From Baseline in Pulmonary Blood Volume (PBV) Over Time: Part 2 Functional Respiratory Imaging (FRI) Period CFB at 3 hours	—	—	—	—	—	—	—	—	—	—	2 Percentage change	—	2 Percentage change	9 Percentage change	—	—	—	—	—
Percentage Change From Baseline in Pulmonary Blood Volume (PBV) Over Time: Part 2 Functional Respiratory Imaging (FRI) Period CFB at 8 hours	—	—	—	—	—	—	—	—	—	—	3 Percentage change	—	11 Percentage change	9 Percentage change	—	—	—	—	—
Percentage Change From Baseline in Pulmonary Blood Volume (PBV) Over Time: Part 2 Functional Respiratory Imaging (FRI) Period CFB at 24 hours	—	—	—	—	—	—	—	—	—	—	-2 Percentage change	—	3 Percentage change	6 Percentage change	—	—	—	—	—

Adverse Events

MK-5475 120 ug: Part 1 (Panel A)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

MK-5475 165 ug: Part 1 (Panel A)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

MK-5475 240 ug: Part 1 (Panel A)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

MK-5475 300 ug: Part 2 Period 1 (Panels B+C)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

MK-5475 480 ug: Part 2 Period 1 (Panel D)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo: Part 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

MK-5475 120 ug: RHC (Panel D)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

MK-5475 165 ug: RHC (Panel B)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

MK-5475 240 ug: RHC (Panel A)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

MK-5475 360 ug: RHC (Panels B+C)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

MK-5475 120 ug: FRI (Panels C+D)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

MK-5475 165 ug: FRI (Panel B)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MK-5475 240 ug: FRI (Panel A)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MK-5475 360 ug: FRI (Panels B+C)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MK-5475 120 ug: Part 1 (Panel A) n=6 participants at risk Participants received MK-5475 120 ug during Part 1.	MK-5475 165 ug: Part 1 (Panel A) n=6 participants at risk Participants received MK-5475 165 ug during Part 1.	MK-5475 240 ug: Part 1 (Panel A) n=6 participants at risk Participants received MK-5475 240 ug during Part 1.	MK-5475 300 ug: Part 2 Period 1 (Panels B+C) n=13 participants at risk Participants received MK-5475 300 ug during Part 2 Period 1.	MK-5475 480 ug: Part 2 Period 1 (Panel D) n=4 participants at risk Participants received MK-5475 480 ug during Part 2 Period 1.	Placebo: Part 1 n=6 participants at risk Participants received placebo during Part 1.	MK-5475 120 ug: RHC (Panel D) n=7 participants at risk Participants received MK-5475 120 ug during the RHC Period.	MK-5475 165 ug: RHC (Panel B) n=1 participants at risk Participant received MK-5475 165 ug during the RHC Period.	MK-5475 240 ug: RHC (Panel A) n=7 participants at risk Participants received MK-5475 240 ug during the RHC Period.	MK-5475 360 ug: RHC (Panels B+C) n=8 participants at risk Participants received MK-5475 360 ug during the RHC Period.	MK-5475 120 ug: FRI (Panels C+D) n=8 participants at risk Participants received MK-5475 120 ug during the FRI Period.	MK-5475 165 ug: FRI (Panel B) n=1 participants at risk Participant received MK-5475 165 ug during the FRI Period.	MK-5475 240 ug: FRI (Panel A) n=7 participants at risk Participants received MK-5475 240 ug during the FRI Period.	MK-5475 360 ug: FRI (Panels B+C) n=8 participants at risk Participants received MK-5475 360 ug during the FRI Period.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Flatulence	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	28.6% 2/7 • Number of events 2 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Immune system disorders Contrast media allergy	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Infections and infestations Chronic sinusitis	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Infections and infestations Rhinitis	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	16.7% 1/6 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	16.7% 1/6 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Investigations Blood alkaline phosphatase increased	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 2 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Investigations Blood creatinine increased	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Investigations Blood pressure increased	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Investigations Weight increased	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	42.9% 3/7 • Number of events 3 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	100.0% 1/1 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	57.1% 4/7 • Number of events 4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	37.5% 3/8 • Number of events 3 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of bone	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Benign enlargement of the subarachnoid spaces	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	14.3% 1/7 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Headache	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Anxiety	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/13 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	7.7% 1/13 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	0.00% 0/7 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to ~14 days after last dose of treatment period (Up to ~32 weeks total) All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

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