Trial Outcomes & Findings for Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation (NCT NCT04539262)

NCT ID: NCT04539262

Last Updated: 2022-03-03

Results Overview

Time-weighted average change in SARS-CoV-2 viral load was defined as area under the concentration versus time curve (AUC) of viral load change divided by time between baseline through Day 7.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 156 participants
• Primary outcome timeframe: Baseline, Day 7
• Results posted on: 2022-03-03

Participant Flow

Participants were enrolled at study sites in the United States. The first participant was screened on 14 September 2020. The last study visit occurred on 22 March 2021.

168 participants were screened.

Participant milestones

Measure	Remdesivir (RDV), Part A Participants received inhaled remdesivir (RDV) 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Overall Study STARTED	12	13	12	12	12	13	62	20
Overall Study COMPLETED	12	12	11	11	12	13	61	20
Overall Study NOT COMPLETED	0	1	1	1	0	0	1	0

Reasons for withdrawal

Measure	Remdesivir (RDV), Part A Participants received inhaled remdesivir (RDV) 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Overall Study Adverse Event	0	0	1	0	0	0	0	0
Overall Study Withdrew Consent	0	0	0	1	0	0	0	0
Overall Study Randomized, Not treated	0	1	0	0	0	0	1	0

Baseline Characteristics

Participants in the Safety Analysis Set with available data were analyzed.

Baseline characteristics by cohort

Measure	RDV, Part A n=12 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=12 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=12 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=12 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=12 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=13 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=61 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=20 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.	Total n=154 Participants Total of all reporting groups
Age, Customized < 60 years	10 Participants n=12 Participants	11 Participants n=12 Participants	9 Participants n=12 Participants	12 Participants n=12 Participants	10 Participants n=12 Participants	12 Participants n=13 Participants	55 Participants n=61 Participants	15 Participants n=20 Participants	134 Participants n=154 Participants
Age, Customized ≥ 60 years	2 Participants n=12 Participants	1 Participants n=12 Participants	3 Participants n=12 Participants	0 Participants n=12 Participants	2 Participants n=12 Participants	1 Participants n=13 Participants	6 Participants n=61 Participants	5 Participants n=20 Participants	20 Participants n=154 Participants
Sex: Female, Male Female	8 Participants n=12 Participants	5 Participants n=12 Participants	4 Participants n=12 Participants	7 Participants n=12 Participants	5 Participants n=12 Participants	6 Participants n=13 Participants	34 Participants n=61 Participants	8 Participants n=20 Participants	77 Participants n=154 Participants
Sex: Female, Male Male	4 Participants n=12 Participants	7 Participants n=12 Participants	8 Participants n=12 Participants	5 Participants n=12 Participants	7 Participants n=12 Participants	7 Participants n=13 Participants	27 Participants n=61 Participants	12 Participants n=20 Participants	77 Participants n=154 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=12 Participants	3 Participants n=12 Participants	3 Participants n=12 Participants	2 Participants n=12 Participants	6 Participants n=12 Participants	4 Participants n=13 Participants	40 Participants n=61 Participants	14 Participants n=20 Participants	78 Participants n=154 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=12 Participants	9 Participants n=12 Participants	9 Participants n=12 Participants	10 Participants n=12 Participants	4 Participants n=12 Participants	9 Participants n=13 Participants	21 Participants n=61 Participants	6 Participants n=20 Participants	74 Participants n=154 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	2 Participants n=12 Participants	0 Participants n=13 Participants	0 Participants n=61 Participants	0 Participants n=20 Participants	2 Participants n=154 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=12 Participants	1 Participants n=12 Participants	1 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=13 Participants	0 Participants n=61 Participants	0 Participants n=20 Participants	2 Participants n=154 Participants
Race/Ethnicity, Customized Race · Black	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	1 Participants n=12 Participants	1 Participants n=13 Participants	12 Participants n=61 Participants	2 Participants n=20 Participants	16 Participants n=154 Participants
Race/Ethnicity, Customized Race · White	11 Participants n=12 Participants	9 Participants n=12 Participants	10 Participants n=12 Participants	11 Participants n=12 Participants	10 Participants n=12 Participants	12 Participants n=13 Participants	47 Participants n=61 Participants	16 Participants n=20 Participants	126 Participants n=154 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=13 Participants	1 Participants n=61 Participants	1 Participants n=20 Participants	2 Participants n=154 Participants
Race/Ethnicity, Customized Race · Not Permitted	1 Participants n=12 Participants	2 Participants n=12 Participants	1 Participants n=12 Participants	0 Participants n=12 Participants	1 Participants n=12 Participants	0 Participants n=13 Participants	0 Participants n=61 Participants	0 Participants n=20 Participants	5 Participants n=154 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	1 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=13 Participants	1 Participants n=61 Participants	1 Participants n=20 Participants	3 Participants n=154 Participants
SARS-CoV-2 Viral load - Nasopharyngeal	7.29 log10 copies/mL STANDARD_DEVIATION 1.901 • n=12 Participants • Participants in the Safety Analysis Set with available data were analyzed.	6.56 log10 copies/mL STANDARD_DEVIATION 1.065 • n=11 Participants • Participants in the Safety Analysis Set with available data were analyzed.	6.81 log10 copies/mL STANDARD_DEVIATION 1.065 • n=12 Participants • Participants in the Safety Analysis Set with available data were analyzed.	5.23 log10 copies/mL STANDARD_DEVIATION 1.980 • n=10 Participants • Participants in the Safety Analysis Set with available data were analyzed.	6.41 log10 copies/mL STANDARD_DEVIATION 1.883 • n=10 Participants • Participants in the Safety Analysis Set with available data were analyzed.	7.09 log10 copies/mL STANDARD_DEVIATION 1.288 • n=13 Participants • Participants in the Safety Analysis Set with available data were analyzed.	5.69 log10 copies/mL STANDARD_DEVIATION 2.004 • n=57 Participants • Participants in the Safety Analysis Set with available data were analyzed.	5.76 log10 copies/mL STANDARD_DEVIATION 1.839 • n=18 Participants • Participants in the Safety Analysis Set with available data were analyzed.	6.14 log10 copies/mL STANDARD_DEVIATION 1.859 • n=143 Participants • Participants in the Safety Analysis Set with available data were analyzed.
SARS-CoV-2 Viral load - Oropharyngeal	5.69 log10 copies/mL STANDARD_DEVIATION 0.959 • n=11 Participants • Participants in the Safety Analysis Set with available data were analyzed.	4.74 log10 copies/mL STANDARD_DEVIATION 1.225 • n=11 Participants • Participants in the Safety Analysis Set with available data were analyzed.	5.57 log10 copies/mL STANDARD_DEVIATION 1.275 • n=12 Participants • Participants in the Safety Analysis Set with available data were analyzed.	4.40 log10 copies/mL STANDARD_DEVIATION 1.772 • n=11 Participants • Participants in the Safety Analysis Set with available data were analyzed.	5.16 log10 copies/mL STANDARD_DEVIATION 1.356 • n=10 Participants • Participants in the Safety Analysis Set with available data were analyzed.	4.79 log10 copies/mL STANDARD_DEVIATION 1.377 • n=12 Participants • Participants in the Safety Analysis Set with available data were analyzed.	4.38 log10 copies/mL STANDARD_DEVIATION 1.610 • n=57 Participants • Participants in the Safety Analysis Set with available data were analyzed.	3.94 log10 copies/mL STANDARD_DEVIATION 1.203 • n=18 Participants • Participants in the Safety Analysis Set with available data were analyzed.	4.64 log10 copies/mL STANDARD_DEVIATION 1.505 • n=142 Participants • Participants in the Safety Analysis Set with available data were analyzed.
SARS-CoV-2 Viral load - Saliva	5.56 log10 copies/mL STANDARD_DEVIATION 1.682 • n=10 Participants • Participants in the Safety Analysis Set with available data were analyzed.	5.19 log10 copies/mL STANDARD_DEVIATION 1.312 • n=11 Participants • Participants in the Safety Analysis Set with available data were analyzed.	4.77 log10 copies/mL STANDARD_DEVIATION 1.218 • n=9 Participants • Participants in the Safety Analysis Set with available data were analyzed.	5.15 log10 copies/mL STANDARD_DEVIATION 2.048 • n=11 Participants • Participants in the Safety Analysis Set with available data were analyzed.	4.77 log10 copies/mL STANDARD_DEVIATION 1.281 • n=10 Participants • Participants in the Safety Analysis Set with available data were analyzed.	5.60 log10 copies/mL STANDARD_DEVIATION 1.074 • n=13 Participants • Participants in the Safety Analysis Set with available data were analyzed.	4.93 log10 copies/mL STANDARD_DEVIATION 1.785 • n=59 Participants • Participants in the Safety Analysis Set with available data were analyzed.	4.57 log10 copies/mL STANDARD_DEVIATION 1.559 • n=19 Participants • Participants in the Safety Analysis Set with available data were analyzed.	5.00 log10 copies/mL STANDARD_DEVIATION 1.613 • n=142 Participants • Participants in the Safety Analysis Set with available data were analyzed.

PRIMARY outcome

Timeframe: Baseline, Day 7

Population: Participants in the Nasopharyngeal Modified Full Analysis Set (mFAS) (all participants who were randomized into the study, had received at least 1 dose of study treatment and had positive SARS-CoV-2 viral load using nasopharyngeal swab sample at baseline \[the result of 'No SARS-CoV-2 detected' was considered as negative\]) with available data were analyzed.

Time-weighted average change in SARS-CoV-2 viral load was defined as area under the concentration versus time curve (AUC) of viral load change divided by time between baseline through Day 7.

Outcome measures

Measure	RDV, Part A n=11 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=11 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=11 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=8 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=10 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=13 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=44 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=16 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Time-weighted Average Change From Baseline in Nasopharyngeal Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 7	-2.04 log10 copies/mL Standard Deviation 0.999	-1.51 log10 copies/mL Standard Deviation 0.812	-1.24 log10 copies/mL Standard Deviation 0.961	-1.21 log10 copies/mL Standard Deviation 1.108	-1.42 log10 copies/mL Standard Deviation 0.975	-1.40 log10 copies/mL Standard Deviation 0.796	-1.91 log10 copies/mL Standard Deviation 1.186	-1.93 log10 copies/mL Standard Deviation 1.284

PRIMARY outcome

Timeframe: Baseline, Day 7

Population: Participants in the Oropharyngeal mFAS (all participants who were randomized into the study, had received at least 1 dose of study treatment and had positive SARS-CoV-2 viral load using oropharyngeal swab sample at baseline \[the result of 'No SARS-CoV-2 detected' was considered as negative\]) with available data were analyzed.

Time-weighted average change in SARS-CoV-2 viral load was defined as AUC of viral load change divided by time between baseline through Day 7.

Outcome measures

Measure	RDV, Part A n=11 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=11 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=11 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=9 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=9 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=11 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=41 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=12 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Time-weighted Average Change From Baseline in Oropharyngeal SARS-CoV-2 Viral Load Through Day 7	-1.10 log10 copies/mL Standard Deviation 0.856	-0.55 log10 copies/mL Standard Deviation 0.868	-1.39 log10 copies/mL Standard Deviation 1.036	-1.14 log10 copies/mL Standard Deviation 1.133	-0.85 log10 copies/mL Standard Deviation 1.164	-0.70 log10 copies/mL Standard Deviation 0.902	-0.83 log10 copies/mL Standard Deviation 1.073	-0.46 log10 copies/mL Standard Deviation 1.152

PRIMARY outcome

Timeframe: Baseline, Day 7

Population: Participants in the saliva mFAS (all participants who were randomized into the study, had received at least 1 dose of study treatment and had positive SARS-CoV-2 viral load using saliva swab sample at baseline \[the result of 'No SARS-CoV-2 detected' was considered as negative\]) with available data were analyzed.

Time-weighted average change in SARS-CoV-2 viral load was defined as AUC of viral load change divided by time between baseline through Day 7.

Outcome measures

Measure	RDV, Part A n=10 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=10 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=8 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=9 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=9 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=12 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=44 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=16 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Time-weighted Average Change From Baseline in Saliva SARS-CoV-2 Viral Load Through Day 7	-0.80 log10 copies/mL Standard Deviation 0.469	-1.27 log10 copies/mL Standard Deviation 0.877	-0.49 log10 copies/mL Standard Deviation 1.148	-1.09 log10 copies/mL Standard Deviation 1.497	-0.61 log10 copies/mL Standard Deviation 0.676	-0.93 log10 copies/mL Standard Deviation 0.678	-1.25 log10 copies/mL Standard Deviation 0.977	-1.01 log10 copies/mL Standard Deviation 1.096

SECONDARY outcome

Timeframe: First dose date up to 5 days plus 30 days

Population: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.

An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug, which did not necessarily have a causal relationship with the treatment. AE was therefore any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. TEAEs: AE with an onset date on or after the study drug start date and no later than 30 days after study drug stop date; or any AE leading to study drug discontinuation.

Outcome measures

Measure	RDV, Part A n=12 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=12 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=12 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=12 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=12 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=13 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=61 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=20 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)	58.3 percentage of participants	58.3 percentage of participants	41.7 percentage of participants	33.3 percentage of participants	58.3 percentage of participants	38.5 percentage of participants	42.6 percentage of participants	25.0 percentage of participants

SECONDARY outcome

Timeframe: First dose date up to 5 days plus 30 days

Population: Participants in the Safety Analysis Set with available data were analyzed.

Treatment-emergent laboratory abnormalities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 July 2017. Laboratory abnormalities were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening). Percentage of participants with any severity grade were reported.

Outcome measures

Measure	RDV, Part A n=12 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=12 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=11 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=11 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=12 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=13 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=61 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=20 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Percentage of Participants With Treatment-Emergent Laboratory Abnormalities as Per Severity Grade	58.3 percentage of participants	91.7 percentage of participants	63.6 percentage of participants	63.6 percentage of participants	83.3 percentage of participants	61.5 percentage of participants	68.9 percentage of participants	75.0 percentage of participants

SECONDARY outcome

Timeframe: First dose date up to 5 days plus 30 days

Population: Participants in the Safety Analysis Set were analyzed.

Outcome measures

Measure	RDV, Part A n=12 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=12 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=12 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=12 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=12 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=13 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=61 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=20 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation	0 percentage of participants	0 percentage of participants	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	1.6 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Randomization up to Day 28

Population: Participants in the Full Analysis Set (all participants who were randomized into the study, and had received at least 1 dose of study treatment) were analyzed.

The composite outcome of all-cause MAVs (medical visits attended in person by the participant and a health care professional) or all-cause death by Study Day 28 were estimated using Kaplan-Meier methods by treatment group.

Outcome measures

Measure	RDV, Part A n=12 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=12 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=12 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=12 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=12 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=13 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=61 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=20 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Number of Participants With All-Cause Medically Attended Visits (MAVs) or Death by Day 28	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Randomization up to Day 28

Population: Participants in the Full Analysis Set were analyzed.

The composite outcome of COVID-19 related MAVs (medical visits attended in person by the participant and a health care professional) or all-cause death by Study Day 28 were estimated using Kaplan-Meier methods by treatment group.

Outcome measures

Measure	RDV, Part A n=12 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=12 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=12 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=12 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=12 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=13 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=61 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=20 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Number of Participants With COVID-19 Related MAVs or Death by Day 28	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 up to Day 28

Population: Participants in the Full Analysis Set were analyzed.

The composite of all-cause hospitalization was estimated using Kaplan-Meier methods by treatment group.

Outcome measures

Measure	RDV, Part A n=12 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=12 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=12 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=12 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=12 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=13 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=61 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=20 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Number of Participants With Hospitalization by Day 28	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Population: As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.

AUC0-24h was defined as the concentration of drug over time between time 0 to time 24 hours. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Population: As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.

AUClast was defined as the concentration of drug from time zero to the last observable concentration.Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Population: As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.

CLss/F was defined as apparent oral clearance at steady state after administration of the drug. CLss/F = Dose/AUCtau, where "Dose" is the dose of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Population: As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.

t1/2 was defined as the estimate of the terminal elimination half-life of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Population: As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.

Vz/F was defined as the apparent volume of distribution of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Population: As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.

Cmax was defined as the maximum observed concentration of drug.Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Population: As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.

Tmax was defined as the time (observed time point) of Cmax. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Population: As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.

Clast was defined as the last observable concentration of drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Population: As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.

Tlast was defined as the time (observed time point) of Clast. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Population: As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.

AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Population: As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.

λz was defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.

Population: As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.

Ctau was defined as the observed drug concentration at the end of the dosing interval. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Day 5

Population: Participants in the Nasopharyngeal mFAS with available data were analyzed.

Outcome measures

Measure	RDV, Part A n=11 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=11 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=11 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=8 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=9 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=12 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=40 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=12 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5	-2.44 log10 copies/mL Standard Deviation 1.240	-1.67 log10 copies/mL Standard Deviation 0.992	-1.78 log10 copies/mL Standard Deviation 1.357	-1.53 log10 copies/mL Standard Deviation 1.063	-1.68 log10 copies/mL Standard Deviation 1.475	-2.09 log10 copies/mL Standard Deviation 1.052	-2.01 log10 copies/mL Standard Deviation 1.402	-2.06 log10 copies/mL Standard Deviation 1.321

SECONDARY outcome

Timeframe: Baseline, Day 5

Population: Participants in the Oropharyngeal mFAS with available data were analyzed.

Outcome measures

Measure	RDV, Part A n=11 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=10 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=11 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=8 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=9 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=9 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=40 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=12 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5	-1.24 log10 copies/mL Standard Deviation 0.957	-0.88 log10 copies/mL Standard Deviation 0.839	-1.26 log10 copies/mL Standard Deviation 1.418	-1.29 log10 copies/mL Standard Deviation 1.457	-1.13 log10 copies/mL Standard Deviation 1.394	-1.10 log10 copies/mL Standard Deviation 0.988	-0.92 log10 copies/mL Standard Deviation 1.213	-0.66 log10 copies/mL Standard Deviation 1.581

SECONDARY outcome

Timeframe: Baseline, Day 5

Population: Participants in the Saliva mFAS with available data were analyzed.

Outcome measures

Measure	RDV, Part A n=10 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=8 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=8 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=8 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=7 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=10 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=42 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=14 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 5	-0.99 log10 copies/mL Standard Deviation 0.562	-1.26 log10 copies/mL Standard Deviation 1.288	-0.77 log10 copies/mL Standard Deviation 1.449	-1.60 log10 copies/mL Standard Deviation 1.443	-0.31 log10 copies/mL Standard Deviation 0.708	-0.92 log10 copies/mL Standard Deviation 1.040	-1.36 log10 copies/mL Standard Deviation 1.056	-1.15 log10 copies/mL Standard Deviation 0.962

SECONDARY outcome

Timeframe: Baseline, Day 7

Population: Participants in the Nasopharyngeal mFAS with available data were analyzed.

Outcome measures

Measure	RDV, Part A n=11 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=9 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=11 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=8 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=10 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=10 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=39 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=15 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7	-3.05 log10 copies/mL Standard Deviation 1.225	-2.12 log10 copies/mL Standard Deviation 1.051	-2.09 log10 copies/mL Standard Deviation 1.331	-1.80 log10 copies/mL Standard Deviation 1.389	-2.30 log10 copies/mL Standard Deviation 1.257	-2.34 log10 copies/mL Standard Deviation 1.873	-2.64 log10 copies/mL Standard Deviation 1.299	-2.62 log10 copies/mL Standard Deviation 1.555

SECONDARY outcome

Timeframe: Baseline, Day 7

Population: Participants in the Oropharyngeal mFAS with available data were analyzed.

Outcome measures

Measure	RDV, Part A n=11 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=9 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=10 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=8 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=9 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=9 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=36 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=10 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7	-1.76 log10copies/mL Standard Deviation 1.113	-0.40 log10copies/mL Standard Deviation 1.049	-1.98 log10copies/mL Standard Deviation 0.971	-1.73 log10copies/mL Standard Deviation 1.513	-1.08 log10copies/mL Standard Deviation 1.160	-1.27 log10copies/mL Standard Deviation 0.845	-1.07 log10copies/mL Standard Deviation 1.122	-0.62 log10copies/mL Standard Deviation 1.606

SECONDARY outcome

Timeframe: Baseline, Day 7

Population: Participants in the Saliva mFAS with available data were analyzed.

Outcome measures

Measure	RDV, Part A n=10 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=8 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=7 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=8 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=9 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=8 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=38 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=15 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 7	-1.28 log10 copies/mL Standard Deviation 1.102	-1.24 log10 copies/mL Standard Deviation 2.108	-0.62 log10 copies/mL Standard Deviation 1.406	-1.91 log10 copies/mL Standard Deviation 1.667	-0.99 log10 copies/mL Standard Deviation 0.943	-1.53 log10 copies/mL Standard Deviation 1.553	-1.69 log10 copies/mL Standard Deviation 1.302	-1.31 log10 copies/mL Standard Deviation 1.752

SECONDARY outcome

Timeframe: Baseline, Day 14

Population: Participants in the Nasopharyngeal mFAS with available were analyzed.

Outcome measures

Measure	RDV, Part A n=11 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=10 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=8 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=6 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=9 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=11 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B	-4.11 log10 copies/mL Standard Deviation 1.304	-2.96 log10 copies/mL Standard Deviation 1.475	-3.31 log10 copies/mL Standard Deviation 1.198	-2.82 log10 copies/mL Standard Deviation 1.888	-2.86 log10 copies/mL Standard Deviation 1.837	-3.41 log10 copies/mL Standard Deviation 1.442	—	—

SECONDARY outcome

Timeframe: Baseline, Day 14

Population: Participants in the Oropharyngeal mFAS with available were analyzed.

Outcome measures

Measure	RDV, Part A n=10 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=10 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=11 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=6 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=7 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=8 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B	-2.46 log10 copies/mL Standard Deviation 0.908	-1.47 log10 copies/mL Standard Deviation 0.841	-2.36 log10 copies/mL Standard Deviation 0.951	-1.46 log10 copies/mL Standard Deviation 1.194	-1.95 log10 copies/mL Standard Deviation 1.283	-2.05 log10 copies/mL Standard Deviation 1.092	—	—

SECONDARY outcome

Timeframe: Baseline, Day 14

Population: Participants in the Saliva mFAS with available were analyzed.

Outcome measures

Measure	RDV, Part A n=9 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=8 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=6 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=6 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=8 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=3 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B	-2.58 log10 copies/mL Standard Deviation 1.413	-2.27 log10 copies/mL Standard Deviation 1.136	-1.78 log10 copies/mL Standard Deviation 0.618	-2.30 log10 copies/mL Standard Deviation 1.505	-2.11 log10 copies/mL Standard Deviation 1.171	-3.53 log10 copies/mL Standard Deviation 1.253	—	—

SECONDARY outcome

Timeframe: Baseline up to Day 17

Population: Participants in the Nasopharyngeal mFAS with available data were analyzed.

The time to negative nasopharyngeal SARS-CoV-2 PCR was defined as the number of days to first confirmed negative (first date of two consecutive dates achieving negative result) using nasopharyngeal sample. Time to negative nasopharyngeal SARS-CoV-2 PCR was calculated using Kaplan-Meier estimates.

Outcome measures

Measure	RDV, Part A n=11 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=11 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=11 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=8 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=10 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=13 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=46 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=16 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Time to Negative Nasopharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR)	NA days Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.	17.0 days Interval 16.0 to 17.0	NA days Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.	16.0 days Interval 7.0 to 16.0	NA days Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.	NA days Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.	NA days Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.	NA days Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.

SECONDARY outcome

Timeframe: Baseline up to Day 17

Population: Participants in the Oropharyngeal mFAS with available data were analyzed.

The time to negative oropharyngeal SARS-CoV-2 PCR was defined as the number of days to first confirmed negative (first date of two consecutive dates achieving negative result) using an oropharyngeal sample. Time to negative oropharyngeal SARS-CoV-2 PCR was calculated using Kaplan-Meier estimates.

Outcome measures

Measure	RDV, Part A n=11 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=11 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=11 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=9 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=9 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=11 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=41 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=12 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Time to Negative Oropharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR)	14.0 days Interval 5.0 to 15.0	15.0 days Interval 4.0 to 16.0	13.0 days Interval 7.0 to Due to smaller number of participants with an event, upper limit of 95% CI could not be calculated.	5.0 days Interval 2.0 to 15.0	NA days Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.	14.0 days Interval 5.0 to 15.0	NA days Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.	NA days Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.

SECONDARY outcome

Timeframe: Baseline up to Day 17

Population: Participants in the Saliva mFAS with available data were analyzed.

The time to saliva SARS-CoV-2 PCR was defined as the number of days to first confirmed negative (first date of two consecutive dates achieving negative result) using saliva sample. Time to negative saliva SARS-CoV-2 PCR was calculated using Kaplan-Meier estimates.

Outcome measures

Measure	RDV, Part A n=11 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=10 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=8 Participants Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=10 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=9 Participants Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=12 Participants Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=45 Participants Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=16 Participants Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Time to Negative Saliva SARS-CoV-2 Polymerase Chain Reaction (PCR)	NA days Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.	17.0 days Interval 13.0 to 17.0	NA days Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.	16.0 days Interval 7.0 to 16.0	14.0 days Interval 3.0 to 15.0	NA days Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.	NA days Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.	16.0 days Interval 7.0 to 16.0

SECONDARY outcome

Timeframe: First dose date up to Day 14

Population: Participants in FAS with available data were analyzed.

The InFLUenza Patient-Reported Outcome (FLU-PRO©) is a 32-item patient-reported outcome questionnaire that assesses the severity of symptoms of influenza and influenza-like illness across six body systems. An additional two items can be added to assess changes in taste or smell, if the instrument is used to quantify symptoms in studies of COVID-19. Each domain scores ranges from 0 (symptom-free) to 4 (very severe symptoms). Higher scores on this scale represent higher disease severity. Alleviation is defined as symptom scores as 2 or higher at baseline are scored as 0 (absent) or 1 (mild) at post-baseline, and symptoms scored as 1 at baseline are scored as 0 at post-baseline, and for two consecutive days. Time to alleviation was calculated using Kaplan-Meier estimates.

Outcome measures

Measure	RDV, Part A n=39 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=9 Participants Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Time to Alleviation (Mild or Absent) of Baseline COVID-19 Symptoms as Reported on the COVID-19 Adapted InFLUenza Patient-Reported Outcome (FLU-PRO©) Questionnaire in Part C	NA days Since less than 50% of participants achieved alleviation, the median time to alleviation couldn't be calculated.	NA days Since less than 50% of participants achieved alleviation, the median time to alleviation couldn't be calculated.	—	—	—	—	—	—

Adverse Events

RDV, Part A

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

RDV + Placebo, Part A

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo, Part A

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

RDV, Part B

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

RDV + Placebo, Part B

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo, Part B

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

RDV, Part C

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo, Part C

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	RDV, Part A n=12 participants at risk Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=12 participants at risk Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=12 participants at risk Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=12 participants at risk Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=12 participants at risk Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=13 participants at risk Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=61 participants at risk Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=20 participants at risk Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Cardiac disorders Acute myocardial infarction	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
General disorders Incarcerated hernia	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Infections and infestations Covid-19 pneumonia	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	7.7% 1/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.

Other adverse events

Measure	RDV, Part A n=12 participants at risk Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part A n=12 participants at risk Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part A n=12 participants at risk Participants received placebo to match inhaled RDV in Part A daily for 5 days.	RDV, Part B n=12 participants at risk Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.	RDV + Placebo, Part B n=12 participants at risk Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.	Placebo, Part B n=13 participants at risk Participants received placebo to match inhaled RDV in Part B daily for 5 days.	RDV, Part C n=61 participants at risk Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.	Placebo, Part C n=20 participants at risk Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Nervous system disorders Ageusia	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	1.6% 1/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Nervous system disorders Anosmia	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	1.6% 1/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Blood and lymphatic system disorders Neutropenia	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Blood and lymphatic system disorders Neutrophilia	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	7.7% 1/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Ear and labyrinth disorders Tinnitus	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Eye disorders Lacrimation increased	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	1.6% 1/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	10.0% 2/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Eye disorders Photophobia	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	1.6% 1/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	5.0% 1/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Gastrointestinal disorders Abdominal distension	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	7.7% 1/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	4.9% 3/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	5.0% 1/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Gastrointestinal disorders Dyspepsia	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Gastrointestinal disorders Nausea	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.2% 5/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Gastrointestinal disorders Toothache	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Gastrointestinal disorders Vomiting	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	16.7% 2/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
General disorders Chest discomfort	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	1.6% 1/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
General disorders Non-cardiac chest pain	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Infections and infestations Otitis media viral	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Infections and infestations Sinusitis	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations Alanine aminotransferase increased	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	7.7% 1/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	3.3% 2/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations Aspartate aminotransferase increased	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	16.7% 2/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	1.6% 1/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations Blood creatine phosphokinase increased	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations Blood glucose increased	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	1.6% 1/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations Blood phosphorus decreased	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations Blood potassium increased	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations Gamma-glutamyltransferase increased	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	1.6% 1/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations Hepatic enzyme abnormal	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations Hepatic enzyme increased	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	1.6% 1/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations Lipase increased	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	7.7% 1/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations Lymphocyte count increased	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations Neutrophil count decreased	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations Platelet count decreased	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations Platelet count increased	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	7.7% 1/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations Transaminases increased	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations White blood cell count decreased	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Investigations White blood cell count increased	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	7.7% 1/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	1.6% 1/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	5.0% 1/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Metabolism and nutrition disorders Haemochromatosis	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Musculoskeletal and connective tissue disorders Back pain	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	1.6% 1/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	5.0% 1/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	7.7% 1/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Nervous system disorders Dizziness	25.0% 3/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.2% 5/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	5.0% 1/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Nervous system disorders Dysgeusia	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	4.9% 3/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Nervous system disorders Head discomfort	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Nervous system disorders Headache	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	4.9% 3/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Nervous system disorders Hypoaesthesia	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Psychiatric disorders Anxiety	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Psychiatric disorders Depression	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	7.7% 1/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Reproductive system and breast disorders Menorrhagia	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Reproductive system and breast disorders Menstruation irregular	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	9.8% 6/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	5.0% 1/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	7.7% 1/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	7.7% 1/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.2% 5/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	3.3% 2/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	6.6% 4/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	5.0% 1/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	3.3% 2/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	5.0% 1/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	3.3% 2/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	10.0% 2/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Vascular disorders Hypertension	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Vascular disorders Orthostatic hypotension	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	8.3% 1/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/12 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/13 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/61 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/20 • Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: GileadClinicalTrials@gilead.com

Results disclosure agreements

• Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
• Publication restrictions are in place

Restriction type: OTHER