Trial Outcomes & Findings for Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008) (NCT NCT05450198)

Last Updated: 2025-06-05

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

72 participants

Primary outcome timeframe

Up to approximately 169 days

Results posted on

2025-06-05

Participant Flow

Participants were enrolled in this study and received MK-6194 or Placebo in Panels A through F. Panels were pre-specified in the protocol to be pooled at dose group level. The exact dose value is proprietary, and directionality is provided.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	MK-6194 Low Dose (Panel A) Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	MK-6194 High Dose (Panel B-E) Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	MK-6194 High Dose (Panel F) Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.
Overall Study STARTED	18	6	36	12
Overall Study COMPLETED	16	5	32	11
Overall Study NOT COMPLETED	2	1	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	MK-6194 Low Dose (Panel A) Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	MK-6194 High Dose (Panel B-E) Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	MK-6194 High Dose (Panel F) Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.
Overall Study Withdrawal by Subject	1	1	2	0
Overall Study Lost to Follow-up	1	0	2	1

Baseline Characteristics

Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=18 Participants Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	MK-6194 Low Dose (Panel A) n=6 Participants Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	MK-6194 High Dose (Panel B-E) n=36 Participants Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	MK-6194 High Dose (Panel F) n=12 Participants Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.	Total n=72 Participants Total of all reporting groups
Age, Continuous	37.2 Years STANDARD_DEVIATION 11.0 • n=5 Participants	46.5 Years STANDARD_DEVIATION 11.3 • n=7 Participants	42.8 Years STANDARD_DEVIATION 16.8 • n=5 Participants	42.0 Years STANDARD_DEVIATION 16.5 • n=4 Participants	41.6 Years STANDARD_DEVIATION 15.0 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	18 Participants n=5 Participants	5 Participants n=4 Participants	30 Participants n=21 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	4 Participants n=7 Participants	18 Participants n=5 Participants	7 Participants n=4 Participants	42 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	6 Participants n=7 Participants	30 Participants n=5 Participants	11 Participants n=4 Participants	62 Participants n=21 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
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	6 Participants n=7 Participants	31 Participants n=5 Participants	10 Participants n=4 Participants	61 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to approximately 169 days

Population: The analysis population consisted of all participants who received ≥1 dose of study intervention. Panels were pre-specified in the protocol to be pooled at dose group level.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	MK-6194 Low Dose (Panel A) n=6 Participants Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	MK-6194 High Dose (Panel B-E) n=36 Participants Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	MK-6194 High Dose (Panel F) n=12 Participants Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.	MK-6194 Total n=54 Participants Participants in Panels A through F.
Number of Participants Who Experience One or More Adverse Events (AEs)	13 Participants	6 Participants	30 Participants	9 Participants	45 Participants

PRIMARY outcome

Timeframe: Up to approximately 85 days

Population: The analysis population consisted of all participants who received ≥1 dose of study intervention. Panels were pre-specified in the protocol to be pooled at dose group level.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	MK-6194 Low Dose (Panel A) n=6 Participants Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	MK-6194 High Dose (Panel B-E) n=36 Participants Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	MK-6194 High Dose (Panel F) n=12 Participants Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.	MK-6194 Total n=54 Participants Participants in Panels A through F.
Number of Participants Who Discontinue Study Intervention Due to an AE	0 Participants	1 Participants	2 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 1 (Predose and 12 hours postdose), Day 8, and Day 15

Population: The analysis population consisted of all participants who were randomized to MK-6194 and had data available. Samples were excluded if they were at the lower limit of quantification (BLQ) or unevaluable. Samples received thawed were unevaluable. For the Placebo arm, zero participants analyzed indicate data were not generated and no data were available. Panels were pre-specified in the protocol to be pooled at dose group level.

Blood samples were collected at pre-specified time points to determine the AUC1-15 of MK-6194 in plasma.

Outcome measures

Outcome measures
Measure	Placebo Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	MK-6194 Low Dose (Panel A) n=2 Participants Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	MK-6194 High Dose (Panel B-E) n=15 Participants Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	MK-6194 High Dose (Panel F) Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.	MK-6194 Total Participants in Panels A through F.
Area Under the Curve (AUC) From Days 1-15 (AUC1-15) of MK-6194	—	32.3 day*ng/mL Interval 13.9 to 75.1	59.6 day*ng/mL Interval 43.8 to 81.1	—	—

SECONDARY outcome

Timeframe: Day 29 (Predose and 12 hours postdose), Day 36, and Day 43

Population: The analysis population consisted of all participants who were randomized to MK-6194 and had data available. Samples were excluded if they were at the BLQ or unevaluable. Samples received thawed were unevaluable. For the Placebo arm, zero participants analyzed indicate data were not generated and no data were available. Panels were pre-specified in the protocol to be pooled at dose group level.

Blood samples were collected at pre-specified time points to determine the AUC29-43 of MK-6194 in plasma.

Outcome measures

Outcome measures
Measure	Placebo Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	MK-6194 Low Dose (Panel A) n=2 Participants Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	MK-6194 High Dose (Panel B-E) n=20 Participants Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	MK-6194 High Dose (Panel F) n=5 Participants Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.	MK-6194 Total Participants in Panels A through F.
AUC From Days 29-43 (AUC29-43) of MK-6194	—	10.9 day*ng/mL Interval 4.13 to 28.7	56.7 day*ng/mL Interval 41.7 to 77.0	86.7 day*ng/mL Interval 47.0 to 160.0	—

SECONDARY outcome

Timeframe: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, and Day 29 (Predose and 12 hours postdose)

Blood samples were collected at pre-specified time points to determine the Cmax of MK-6194 in plasma.

Outcome measures

Outcome measures
Measure	Placebo Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	MK-6194 Low Dose (Panel A) n=4 Participants Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	MK-6194 High Dose (Panel B-E) n=36 Participants Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	MK-6194 High Dose (Panel F) n=12 Participants Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.	MK-6194 Total Participants in Panels A through F.
Peak Serum Concentration (Cmax) of MK-6194 (Day 1 to 29)	—	13.2 ng/mL Interval 6.34 to 27.3	21.7 ng/mL Interval 16.8 to 27.9	20.0 ng/mL Interval 12.9 to 31.1	—

SECONDARY outcome

Timeframe: Predose on Days 15 and 29

Population: The analysis population consisted of all participants who were randomized to MK-6194 and had data available. Samples received thawed were unevaluable. For the Placebo arm, zero participants analyzed indicate data were not generated and no data were available. Panels were pre-specified in the protocol to be pooled at dose group level.

Blood samples were collected at pre-specified time points to determine the Ctrough of MK-6194 in plasma.

Outcome measures

Outcome measures
Measure	Placebo Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	MK-6194 Low Dose (Panel A) Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	MK-6194 High Dose (Panel B-E) n=2 Participants Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	MK-6194 High Dose (Panel F) Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.	MK-6194 Total Participants in Panels A through F.
Minimum Serum Concentration (Ctrough) of MK-6194 (Day 1 to 29)	—	—	0.210 ng/mL Interval 0.0141 to 3.13	—	—

SECONDARY outcome

Timeframe: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, and Day 29 (Predose and 12 hours postdose)

Blood samples were collected at pre-specified time points to determine the Tmax of MK-6194 in plasma.

Outcome measures

Outcome measures
Measure	Placebo Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	MK-6194 Low Dose (Panel A) n=4 Participants Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	MK-6194 High Dose (Panel B-E) n=36 Participants Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	MK-6194 High Dose (Panel F) n=12 Participants Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.	MK-6194 Total Participants in Panels A through F.
Time to Peak Serum Concentration (Tmax) of MK-6194 (Day 1 to 29)	—	0.49 day Interval 0.48 to 0.49	0.49 day Interval 0.48 to 0.51	0.49 day Interval 0.42 to 0.5	—

SECONDARY outcome

Timeframe: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43

Blood samples were collected at pre-specified time points to determine the geometric mean accumulation ratio of AUC of MK-6194. The accumulation ratio is defined as Day 29-43/ Day 1-15.

Outcome measures

Outcome measures
Measure	Placebo Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	MK-6194 Low Dose (Panel A) n=2 Participants Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	MK-6194 High Dose (Panel B-E) n=15 Participants Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	MK-6194 High Dose (Panel F) Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.	MK-6194 Total Participants in Panels A through F.
Geometric Mean Accumulation Ratio of AUC of MK-6194	—	0.35 Ratio Interval 0.13 to 0.96	0.98 Ratio Interval 0.7 to 1.38	—	—

SECONDARY outcome

Timeframe: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43

Blood samples were collected at pre-specified time points to determine the geometric mean accumulation ratio of Cmax of MK-6194. The accumulation ratio is defined as Day 29-43/ Day 1-15.

Outcome measures

Outcome measures
Measure	Placebo Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	MK-6194 Low Dose (Panel A) n=4 Participants Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	MK-6194 High Dose (Panel B-E) n=33 Participants Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	MK-6194 High Dose (Panel F) n=11 Participants Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.	MK-6194 Total Participants in Panels A through F.
Geometric Mean Accumulation Ratio of Cmax of MK-6194	—	0.84 Ratio Interval 0.41 to 1.72	0.98 Ratio Interval 0.79 to 1.2	1.35 Ratio Interval 0.94 to 1.94	—

SECONDARY outcome

Timeframe: Baseline and Day 85

Population: The analysis population consisted of all participants who were randomized to MK-6194 and had data available. Panels were pre-specified in the protocol to be pooled at dose group level.

Blood samples were collected to determine the fold change from baseline (FCB) in peak Tregs. The peak Treg FCB was evaluated after the last dose of MK-6194 on Day 85 using natural-log transformed values with a linear model containing fixed effects.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	MK-6194 Low Dose (Panel A) n=5 Participants Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	MK-6194 High Dose (Panel B-E) n=27 Participants Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	MK-6194 High Dose (Panel F) n=11 Participants Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.	MK-6194 Total Participants in Panels A through F.
Fold Change From Baseline in Peak Regulatory T Cells (Tregs)	1.15 Fold change from baseline Interval 0.83 to 1.59	1.86 Fold change from baseline Interval 0.95 to 3.66	1.69 Fold change from baseline Interval 1.27 to 2.24	1.58 Fold change from baseline Interval 1.05 to 2.38	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

MK-6194 Low Dose (Panel A)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

MK-6194 High Dose (Panels B-E)

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

MK-6194 High Dose (Panel F)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

MK-6194 Total

Serious events: 2 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=18 participants at risk Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	MK-6194 Low Dose (Panel A) n=6 participants at risk Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	MK-6194 High Dose (Panels B-E) n=36 participants at risk Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	MK-6194 High Dose (Panel F) n=12 participants at risk Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.	MK-6194 Total n=54 participants at risk Participants in Panels A through F.
Gastrointestinal disorders Inguinal hernia	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Malaise	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.

Other adverse events

Other adverse events
Measure	Placebo n=18 participants at risk Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	MK-6194 Low Dose (Panel A) n=6 participants at risk Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	MK-6194 High Dose (Panels B-E) n=36 participants at risk Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	MK-6194 High Dose (Panel F) n=12 participants at risk Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.	MK-6194 Total n=54 participants at risk Participants in Panels A through F.
Blood and lymphatic system disorders Anaemia	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	19.4% 7/36 • Number of events 8 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	25.0% 3/12 • Number of events 5 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	20.4% 11/54 • Number of events 14 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	5.6% 2/36 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	3.7% 2/54 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Eye disorders Conjunctivitis allergic	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Gastrointestinal disorders Chronic gastritis	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Gastrointestinal disorders Diarrhoea	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 2/12 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	3.7% 2/54 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Gastrointestinal disorders Flatulence	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/54 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Gastrointestinal disorders Gastritis	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Gastrointestinal disorders Nausea	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	33.3% 2/6 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	3.7% 2/54 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Gastrointestinal disorders Peptic ulcer	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Gastrointestinal disorders Toothache	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Gastrointestinal disorders Vomiting	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Chills	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Fatigue	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	5.6% 2/36 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	5.6% 3/54 • Number of events 3 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Influenza like illness	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	5.6% 2/36 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 2/12 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	7.4% 4/54 • Number of events 4 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Injection site discolouration	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	5.6% 2/36 • Number of events 6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	5.6% 3/54 • Number of events 7 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Injection site erythema	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	100.0% 6/6 • Number of events 19 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	69.4% 25/36 • Number of events 110 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	50.0% 6/12 • Number of events 22 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	68.5% 37/54 • Number of events 151 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Injection site haematoma	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Injection site induration	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	50.0% 3/6 • Number of events 6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	22.2% 8/36 • Number of events 16 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	20.4% 11/54 • Number of events 22 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Injection site oedema	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Injection site pain	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	50.0% 3/6 • Number of events 5 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 6/36 • Number of events 7 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 2/12 • Number of events 5 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	20.4% 11/54 • Number of events 17 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Injection site pruritus	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 3/36 • Number of events 13 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	7.4% 4/54 • Number of events 15 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Injection site swelling	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	19.4% 7/36 • Number of events 16 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	25.0% 3/12 • Number of events 5 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	20.4% 11/54 • Number of events 22 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Injection site urticaria	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Injection site warmth	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Malaise	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Oedema peripheral	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Pain	11.1% 2/18 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
General disorders Pyrexia	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/54 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Anal abscess	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Conjunctivitis	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/54 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Cystitis	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Ear infection	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Gastroenteritis	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Localised infection	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Nasopharyngitis	11.1% 2/18 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 3/36 • Number of events 4 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	41.7% 5/12 • Number of events 6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	14.8% 8/54 • Number of events 10 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Oral herpes	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Paronychia	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Pharyngitis	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/54 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Rhinitis	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/54 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Sinusitis	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/54 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Skin bacterial infection	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Skin infection	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Tonsillitis	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Tooth abscess	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Upper respiratory tract infection	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 3/36 • Number of events 4 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	9.3% 5/54 • Number of events 6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Urinary tract infection	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	3.7% 2/54 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Infections and infestations Viral infection	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Injury, poisoning and procedural complications Contusion	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Injury, poisoning and procedural complications Fall	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Investigations Alanine aminotransferase increased	11.1% 2/18 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/54 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Investigations Aspartate aminotransferase increased	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/54 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Investigations Blood creatine phosphokinase increased	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Investigations Blood lactate dehydrogenase increased	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Investigations Hepatic enzyme increased	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	3.7% 2/54 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Investigations Influenza A virus test positive	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/54 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Investigations Platelet count increased	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Investigations SARS-CoV-2 test positive	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/54 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Investigations White blood cell count increased	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Metabolism and nutrition disorders Hypovitaminosis	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Metabolism and nutrition disorders Vitamin D deficiency	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/54 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Musculoskeletal and connective tissue disorders Joint effusion	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/54 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Nervous system disorders Cognitive disorder	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Nervous system disorders Headache	22.2% 4/18 • Number of events 5 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	11.1% 4/36 • Number of events 4 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	9.3% 5/54 • Number of events 5 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Nervous system disorders Sciatica	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Product Issues Embedded device	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Psychiatric disorders Anxiety	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Psychiatric disorders Initial insomnia	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Psychiatric disorders Insomnia	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Renal and urinary disorders Dysuria	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Renal and urinary disorders Proteinuria	5.6% 1/18 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/54 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	3.7% 2/54 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	5.6% 2/36 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	3.7% 2/54 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 3/18 • Number of events 3 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Respiratory, thoracic and mediastinal disorders Painful respiration	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	5.6% 2/36 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	3.7% 2/54 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Skin and subcutaneous tissue disorders Madarosis	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Skin and subcutaneous tissue disorders Night sweats	5.6% 1/18 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/6 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/54 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	33.3% 2/6 • Number of events 3 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	3.7% 2/54 • Number of events 3 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	3.7% 2/54 • Number of events 2 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Vascular disorders Hypertension	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/36 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	0.00% 0/12 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	1.9% 1/54 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.
Vascular disorders Orthostatic hypotension	0.00% 0/18 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	16.7% 1/6 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	2.8% 1/36 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	8.3% 1/12 • Number of events 1 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.	5.6% 3/54 • Number of events 3 • Up to approximately 169 days All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study treatment. Panels were pre-specified in the protocol to be pooled at dose group level.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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