Trial Outcomes & Findings for Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure (NCT NCT04389840)

NCT ID: NCT04389840

Last Updated: 2022-08-30

Results Overview

The primary efficacy endpoint was to be the proportion of participants who were alive and free of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) through Day 28. Data also shows proportion of participants with invasive mechanical ventilation or ECMO, all-cause mortality, or early study discontinuation (\<Day 25), whichever occurred first, by Day 28.

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 27 participants
• Primary outcome timeframe: Day 1 to Day 28 (28 days)
• Results posted on: 2022-08-30

Participant Flow

Study enrollment was terminated on 20 May 2021 due to improvement in the Coronavirus Disease 2019 (COVID-19) pandemic and low subject accrual. At the time of termination, a total of 27 subjects of the planned 75 subjects had been enrolled, of which 26 subjects were treated and 22 subjects had completed the study across Cohorts 1, 2, and 3 (partial) of the Phase 2 portion of the study.

Participant milestones

Measure	Cohort 1 Dociparstat Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.25 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 1 Placebo Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 2 Dociparstat Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 2 Placebo Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 3 Dociparstat Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 3 Placebo Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).
Overall Study STARTED	6	6	8	4	2	1
Overall Study Intent-to-Treat Analysis Set	6	6	8	4	2	1
Overall Study Safety Analysis Set	6	6	8	3	2	1
Overall Study COMPLETED	4	5	8	3	1	1
Overall Study NOT COMPLETED	2	1	0	1	1	0

Reasons for withdrawal

Measure	Cohort 1 Dociparstat Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.25 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 1 Placebo Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 2 Dociparstat Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 2 Placebo Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 3 Dociparstat Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 3 Placebo Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).
Overall Study Adverse Event	0	0	0	1	0	0
Overall Study Subject request and prohibited concomitant medication	2	0	0	0	1	0
Overall Study Death	0	1	0	0	0	0

Baseline Characteristics

Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure

Baseline characteristics by cohort

Measure	Cohort 1 Dociparstat n=6 Participants Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.25 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 1 Placebo n=6 Participants Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 2 Dociparstat n=8 Participants Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 2 Placebo n=3 Participants Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 3 Dociparstat n=2 Participants Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 3 Placebo n=1 Participants Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Total n=26 Participants Total of all reporting groups
Age, Continuous	50.5 years n=5 Participants	63.0 years n=7 Participants	62.0 years n=5 Participants	62.0 years n=4 Participants	39.5 years n=21 Participants	41 years n=8 Participants	57.0 years n=8 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	15 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	11 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	9 Participants n=8 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	14 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
NIAID Score (actual) 3	2 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	12 Participants n=8 Participants
NIAID Score (actual) 4	4 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	14 Participants n=8 Participants
Body mass index	32.5 kg/m^2 STANDARD_DEVIATION 6.57 • n=5 Participants	33.9 kg/m^2 STANDARD_DEVIATION 5.85 • n=7 Participants	31.0 kg/m^2 STANDARD_DEVIATION 6.17 • n=5 Participants	36.4 kg/m^2 STANDARD_DEVIATION 12.34 • n=4 Participants	28.6 kg/m^2 STANDARD_DEVIATION 5.05 • n=21 Participants	45.4 kg/m^2 STANDARD_DEVIATION NA • n=8 Participants	33.0 kg/m^2 STANDARD_DEVIATION 6.85 • n=8 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 28 (28 days)

Population: Note: This outcome measure was analyzed using the Intent-to-Treat (ITT) Analysis Set. In the ITT Analysis Set included 4 placebo-treated subjects for Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. This subject was randomized to receive placebo but never received treatment due to consent withdrawal.

The primary efficacy endpoint was to be the proportion of participants who were alive and free of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) through Day 28. Data also shows proportion of participants with invasive mechanical ventilation or ECMO, all-cause mortality, or early study discontinuation (<Day 25), whichever occurred first, by Day 28.

Outcome measures

Measure	Cohort 1 Dociparstat n=6 Participants Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.25 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 1 Placebo n=6 Participants Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 2 Dociparstat n=8 Participants Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 2 Placebo n=4 Participants Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 3 Dociparstat n=2 Participants Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 3 Placebo n=1 Participants Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).
Number of Participants Who Are Alive and Free of Invasive Mechanical Ventilation or ECMO Through Day 28	3 Participants	4 Participants	7 Participants	3 Participants	2 Participants	1 Participants

Adverse Events

Cohort 1 Dociparstat

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 1 Placebo

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

Cohort 2 Dociparstat

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 2 Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 3 Dociparstat

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 3 Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort 1 Dociparstat n=6 participants at risk Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.25 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 1 Placebo n=6 participants at risk Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 2 Dociparstat n=8 participants at risk Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 2 Placebo n=3 participants at risk Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 3 Dociparstat n=2 participants at risk Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 3 Placebo n=1 participants at risk Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).
Respiratory, thoracic and mediastinal disorders Respiratory failure	33.3% 2/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
General disorders Multiple organ dysfunction syndrome	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Infections and infestations COVID-19 pneumonia	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Infections and infestations Pneumonia bacterial	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Infections and infestations Sepsis	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Infections and infestations Septic shock	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Vascular disorders Deep vein thrombosis	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Vascular disorders Peripheral artery thrombosis	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Vascular disorders Venous thrombosis limb	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.

Other adverse events

Measure	Cohort 1 Dociparstat n=6 participants at risk Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.25 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 1 Placebo n=6 participants at risk Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 2 Dociparstat n=8 participants at risk Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 2 Placebo n=3 participants at risk Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 3 Dociparstat n=2 participants at risk Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).	Cohort 3 Placebo n=1 participants at risk Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 \[168 hours\]).
Cardiac disorders Atrial fibrillation	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Cardiac disorders Sinus bradycardia	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Metabolism and nutrition disorders Fluid overload	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Metabolism and nutrition disorders Hypocalcaemia	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Metabolism and nutrition disorders Hypokalaemia	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	25.0% 2/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	33.3% 1/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Metabolism and nutrition disorders Lactic acidosis	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Metabolism and nutrition disorders Metabolic acidosis	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Nervous system disorders Encephalopathy	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Nervous system disorders Headache	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Nervous system disorders Visual field defect	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Nervous system disorders Dizziness	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	50.0% 1/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Pleural effusion	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Respiratory failure	33.3% 2/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	50.0% 1/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	33.3% 1/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	33.3% 1/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	50.0% 1/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Gastrointestinal disorders Constipation	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	33.3% 2/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Gastrointestinal disorders Melaena	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Infections and infestations Oesophageal candidiasis	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Infections and infestations Pneumonia bacterial	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Infections and infestations COVID-19 pneumonia	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	33.3% 2/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Infections and infestations Genital herpes	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	33.3% 1/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Infections and infestations Pneumonia staphylococcal	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Infections and infestations Sepsis	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Infections and infestations Septic shock	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Investigations Alanine aminotransferase increased	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Investigations Aspartate aminotransferase increased	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Investigations Blood phosphorous decreased	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Psychiatric disorders Anxiety	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Renal and urinary disorders Urinary retention	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	50.0% 3/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Vascular disorders Deep vein thrombosis	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Vascular disorders Hypotension	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	12.5% 1/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Vascular disorders Peripheral artery thrombosis	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Vascular disorders Thrombophlebitis	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	100.0% 1/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Vascular disorders Venous thrombosis limb	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
General disorders Chest pain	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
General disorders Facial pain	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.
General disorders Multiple organ dysfunction	0.00% 0/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	16.7% 1/6 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/8 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/3 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/2 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.	0.00% 0/1 • From randomization through Day 28 Note: Adverse events were evaluated using the Safety Analysis Set. All-cause mortality was evaluated using the Intent-to-Treat (ITT) Analysis Set. The ITT Analysis Set included 4 placebo-treated subjects from Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. The excluded subject was randomized to receive placebo but never received treatment due to consent withdrawal.

Additional Information

Chief Medical Officer

Chimerix, Inc.

Phone: 919-806-1074

Email: dmoore@chimerix.com

Results disclosure agreements

• Principal investigator is a sponsor employee Within 18 months of the completion of the Study at all sites, if no publication of the overall multi-center results has been made, institutions are entitled to publish their locally obtained results, provided the Sponsor is given opportunity to review and comment. Institution publications may be delayed up to an additional 60 days to allow Sponsor to seek patent protection.
• Publication restrictions are in place

Restriction type: OTHER