Trial Outcomes & Findings for A Study of Auxora in Patients With Critical COVID-19 Pneumonia (NCT NCT04661540)

NCT ID: NCT04661540

Last Updated: 2025-11-21

Results Overview

Pharmacodynamic endpoint: Assessment of pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets to Auxora treatment. Flow cytometry was performed on fluid collected from the BAL performed prior to the SFISD (-12 hours) and 24 (±12) hours after completing the last infusion of study drug in Cohorts 1 and 2 and during the final 24 hours of the continuous infusion in Cohort 3. The percentage of total WBC population was assessed for the combined CD4, CD8, and monocyte cell population, and the change between Pre- and Post-Infusion samples (Post value minus Pre value) was reported.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: Baseline Assessment up to 120 hours
• Results posted on: 2025-11-21

Participant Flow

10 patients were screened, 1 of which did not meet all inclusion/exclusion criteria, resulting in 9 patients randomized. All 9 completed study treatment, and 0 patients withdrew from the study. Patients were randomized 3:1 to Auxora or Placebo. The first 4 patients were enrolled in Cohort 1, and the next 4 in Cohort 2. The next 8 patients were to be enrolled in Cohort 3, but trial terminated early after the first patient was enrolled in Cohort 3, due to lack of new Covid-19 hospitalizations.

Participant milestones

Measure	Auxora Cohort 1 Auxora will be given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 2 Auxora will be given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 3 Auxora will be given as a continuous infusion: Day 1: Patients will initially receive 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients will start a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion).	Placebo Placebo will be given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo will receive 1.25 mL/kg over 4 hours. After initial infusion is complete, patients enrolled during period 3 will then receive a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo will receive 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 will receive 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 will receive 1.0 mL/kg over 4 hours.
Period 1 (Cohort 1) STARTED	3	0	0	1
Period 1 (Cohort 1) COMPLETED	3	0	0	1
Period 1 (Cohort 1) NOT COMPLETED	0	0	0	0
Period 2 (Cohort 2) STARTED	0	3	0	1
Period 2 (Cohort 2) COMPLETED	0	3	0	1
Period 2 (Cohort 2) NOT COMPLETED	0	0	0	0
Period 3 (Cohort 3) STARTED	0	0	1	0
Period 3 (Cohort 3) COMPLETED	0	0	1	0
Period 3 (Cohort 3) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Auxora in Patients With Critical COVID-19 Pneumonia

Baseline characteristics by cohort

Measure	Auxora Cohort 1 n=3 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 2 n=3 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 3 n=1 Participants Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion).	Placebo n=2 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.	Total n=9 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants	1 Participants n=33 Participants	1 Participants n=225 Participants
Race (NIH/OMB) White	1 Participants n=68 Participants	2 Participants n=76 Participants	0 Participants n=48 Participants	1 Participants n=33 Participants	4 Participants n=225 Participants
Age, Continuous	53.0 years STANDARD_DEVIATION 5.2 • n=68 Participants	67.0 years STANDARD_DEVIATION 3.0 • n=76 Participants	46 years STANDARD_DEVIATION NA • n=48 Participants	54 years STANDARD_DEVIATION 1.4 • n=33 Participants	57 years STANDARD_DEVIATION 8.4 • n=225 Participants
Sex: Female, Male Female	1 Participants n=68 Participants	1 Participants n=76 Participants	0 Participants n=48 Participants	1 Participants n=33 Participants	3 Participants n=225 Participants
Sex: Female, Male Male	2 Participants n=68 Participants	2 Participants n=76 Participants	1 Participants n=48 Participants	1 Participants n=33 Participants	6 Participants n=225 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=68 Participants	3 Participants n=76 Participants	1 Participants n=48 Participants	0 Participants n=33 Participants	6 Participants n=225 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants	2 Participants n=33 Participants	3 Participants n=225 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants	0 Participants n=33 Participants	0 Participants n=225 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants	0 Participants n=33 Participants	0 Participants n=225 Participants
Race (NIH/OMB) Asian	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants	0 Participants n=33 Participants	0 Participants n=225 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants	0 Participants n=33 Participants	0 Participants n=225 Participants
Race (NIH/OMB) More than one race	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants	0 Participants n=33 Participants	0 Participants n=225 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=68 Participants	1 Participants n=76 Participants	1 Participants n=48 Participants	0 Participants n=33 Participants	4 Participants n=225 Participants
Region of Enrollment United States	3 participants n=68 Participants	3 participants n=76 Participants	1 participants n=48 Participants	2 participants n=33 Participants	9 participants n=225 Participants
Height	170.3 cm STANDARD_DEVIATION 16.6 • n=68 Participants	164.7 cm STANDARD_DEVIATION 5.8 • n=76 Participants	183 cm STANDARD_DEVIATION NA • n=48 Participants	184.0 cm STANDARD_DEVIATION 12.7 • n=33 Participants	172.9 cm STANDARD_DEVIATION 13.0 • n=225 Participants
Weight	96.7 kg STANDARD_DEVIATION 26.5 • n=68 Participants	78.0 kg STANDARD_DEVIATION 4.4 • n=76 Participants	163.4 kg STANDARD_DEVIATION NA • n=48 Participants	103.5 kg STANDARD_DEVIATION 26.2 • n=33 Participants	99.4 kg STANDARD_DEVIATION 30.9 • n=225 Participants
BMI	33.2 kg/m^2 STANDARD_DEVIATION 6.6 • n=68 Participants	28.9 kg/m^2 STANDARD_DEVIATION 1.6 • n=76 Participants	48.9 kg/m^2 STANDARD_DEVIATION NA • n=48 Participants	30.3 kg/m^2 STANDARD_DEVIATION 3.6 • n=33 Participants	32.9 kg/m^2 STANDARD_DEVIATION 7.3 • n=225 Participants
Number of Participants with Additional Prior Positive Covid Test Yes	3 Participants n=68 Participants	3 Participants n=76 Participants	0 Participants n=48 Participants	1 Participants n=33 Participants	7 Participants n=225 Participants
Number of Participants with Additional Prior Positive Covid Test Unknown	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants	1 Participants n=33 Participants	1 Participants n=225 Participants
Number of Participants with Additional Prior Positive Covid Test No	0 Participants n=68 Participants	0 Participants n=76 Participants	1 Participants n=48 Participants	0 Participants n=33 Participants	1 Participants n=225 Participants
Number of Participants with Upper Respiratory Co-detection of Sars-CoV-2	0 Participants n=68 Participants	1 Participants n=76 Participants	0 Participants n=48 Participants	2 Participants n=33 Participants	3 Participants n=225 Participants
Number of Participants with Bacterial Superinfection at Intubation	1 Participants n=68 Participants	1 Participants n=76 Participants	0 Participants n=48 Participants	0 Participants n=33 Participants	2 Participants n=225 Participants

PRIMARY outcome

Timeframe: Baseline Assessment up to 120 hours

Pharmacodynamic endpoint: Assessment of pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets to Auxora treatment. Flow cytometry was performed on fluid collected from the BAL performed prior to the SFISD (-12 hours) and 24 (±12) hours after completing the last infusion of study drug in Cohorts 1 and 2 and during the final 24 hours of the continuous infusion in Cohort 3. The percentage of total WBC population was assessed for the combined CD4, CD8, and monocyte cell population, and the change between Pre- and Post-Infusion samples (Post value minus Pre value) was reported.

Outcome measures

Measure	Auxora Cohort 1 n=3 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 2 n=3 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 3 n=1 Participants Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion).	Placebo n=2 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.	Placebo Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.
Change From Baseline in Combined CD4, CD8, and Monocyte Cell Population in BAL Fluid, as a Percent of Total WBC Population.	-5.6 Percent of total WBC population Standard Deviation 31.6	-7.2 Percent of total WBC population Standard Deviation 10.7	27.1 Percent of total WBC population Standard Deviation NA Standard deviation cannot be calculated from 1 data point.	22.8 Percent of total WBC population Standard Deviation 9.7	—

SECONDARY outcome

Timeframe: Baseline Assessment up to 120 hours

Pharmacodynamic endpoint: Assessment of pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets to Auxora treatment. Flow cytometry was performed on fluid collected from the BAL performed prior to the SFISD (-12 hours) and 24 (±12) hours after completing the last infusion of study drug in Cohorts 1 and 2 and during the final 24 hours of the continuous infusion in Cohort 3. The percentage of total WBC population was assessed for immune cell types and the change between Pre- and Post-Infusion samples (Post value minus Pre value) was reported.

Outcome measures

Measure	Auxora Cohort 1 n=3 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 2 n=3 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 3 n=1 Participants Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion).	Placebo n=2 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.	Placebo Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.
Change From Baseline in Percent of Immune Cells in BAL Fluid Neutrophils	-14.5 Percent of total WBC population Standard Deviation 43.9	24.4 Percent of total WBC population Standard Deviation 47.1	-4.2 Percent of total WBC population Standard Deviation NA Standard deviation cannot be calculated from a single data point.	-25.7 Percent of total WBC population Standard Deviation 24.0	—
Change From Baseline in Percent of Immune Cells in BAL Fluid CD8 T Cells	-2.0 Percent of total WBC population Standard Deviation 12.5	-0.5 Percent of total WBC population Standard Deviation 4.6	23.1 Percent of total WBC population Standard Deviation NA Standard deviation cannot be calculated from a single data point.	5.3 Percent of total WBC population Standard Deviation 3.9	—
Change From Baseline in Percent of Immune Cells in BAL Fluid CD4 T Cells	-2.4 Percent of total WBC population Standard Deviation 15.7	-3.4 Percent of total WBC population Standard Deviation 6.3	5.9 Percent of total WBC population Standard Deviation NA Standard deviation cannot be calculated from a single data point.	17.9 Percent of total WBC population Standard Deviation 5.4	—
Change From Baseline in Percent of Immune Cells in BAL Fluid NK cells	-0.2 Percent of total WBC population Standard Deviation 1.5	-1.8 Percent of total WBC population Standard Deviation 1.5	0.1 Percent of total WBC population Standard Deviation NA Standard deviation cannot be calculated from a single data point.	0.3 Percent of total WBC population Standard Deviation 1.3	—
Change From Baseline in Percent of Immune Cells in BAL Fluid Monocytes	-1.2 Percent of total WBC population Standard Deviation 10.0	-3.3 Percent of total WBC population Standard Deviation 5.8	-13.4 Percent of total WBC population Standard Deviation NA Standard deviation cannot be calculated from a single data point.	-0.4 Percent of total WBC population Standard Deviation 0.3	—
Change From Baseline in Percent of Immune Cells in BAL Fluid B cells	14.2 Percent of total WBC population Standard Deviation 10.4	-12.4 Percent of total WBC population Standard Deviation 14.3	3.2 Percent of total WBC population Standard Deviation NA Standard deviation cannot be calculated from a single data point.	-23.2 Percent of total WBC population Standard Deviation 29.9	—
Change From Baseline in Percent of Immune Cells in BAL Fluid Macrophages	6.3 Percent of total WBC population Standard Deviation 20.0	-2.3 Percent of total WBC population Standard Deviation 23.1	-3.8 Percent of total WBC population Standard Deviation NA Standard deviation cannot be calculated from a single data point.	25.2 Percent of total WBC population Standard Deviation 16.9	—

SECONDARY outcome

Timeframe: Randomization through Day 60

Efficacy endpoint: All-cause Mortality at Day 60

Outcome measures

Measure	Auxora Cohort 1 n=7 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 2 n=3 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 3 n=3 Participants Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion).	Placebo n=1 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.	Placebo n=2 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.
Number of Patients Alive at Day 60	3 Participants	1 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From randomization until discharge from ICU, assessed up to 60 days

Efficacy Endpoint: Days in ICU (after randomization)

Outcome measures

Measure	Auxora Cohort 1 n=7 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 2 n=3 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 3 n=3 Participants Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion).	Placebo n=1 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.	Placebo n=2 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.
Number of Days Alive and Out of the Intensive Care Unit (ICU)	4.6 days Standard Deviation 8.0	6.3 days Standard Deviation 11.0	0 days Standard Deviation 0	13.0 days Standard Deviation NA Standard deviation cannot be calculated off of 1 data point.	0 days Standard Deviation 0

SECONDARY outcome

Timeframe: From randomization until discharge from the hospital, assessed up to 60 days

Efficacy endpoint: Days hospitalized (after randomization)

Outcome measures

Measure	Auxora Cohort 1 n=7 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 2 n=3 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 3 n=3 Participants Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion).	Placebo n=1 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.	Placebo n=2 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.
Number of Days Alive and Out of the Hospital	1.0 days Standard Deviation 2.6	0 days Standard Deviation 0	0 days Standard Deviation 0	7.0 days Standard Deviation NA Standard deviation cannot be calculated off of 1 data point.	0 days Standard Deviation 0

SECONDARY outcome

Timeframe: From randomization until patient is extubated, assessed up to 60 days

Efficacy endpoint: Ventilator-free days (after randomization)

Outcome measures

Measure	Auxora Cohort 1 n=7 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 2 n=3 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 3 n=3 Participants Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion).	Placebo n=1 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.	Placebo n=2 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.
Number of Days Alive and Off Mechanical Ventilation	5.9 days Standard Deviation 10.2	8.0 days Standard Deviation 13.9	0 days Standard Deviation 0	17.0 days Standard Deviation NA Standard deviation cannot be calculated off of 1 data point.	0 days Standard Deviation 0

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization through Day 30

Safety endpoint. Examines the relatedness of AEs to study drug by assessing the number of patients experiencing any AE (serious or non-serious) considered possibly related to Study Drug.

Outcome measures

Measure	Auxora Cohort 1 n=7 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 2 n=3 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 3 n=3 Participants Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion).	Placebo n=1 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.	Placebo n=2 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.
Number of Patients Experiencing an AE Considered Possibly Related to Study Drug Possibly related SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Patients Experiencing an AE Considered Possibly Related to Study Drug Possibly related non-serious AEs	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization through day 30

Safety Endpoint: Incidence of treatment emergent Serious Adverse Events (SAEs)

Outcome measures

Measure	Auxora Cohort 1 n=7 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 2 n=3 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 3 n=3 Participants Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion).	Placebo n=1 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.	Placebo n=2 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.
Number of Patients Experiencing an SAE (at Least 1)	4 Participants	1 Participants	3 Participants	0 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization through Day 30

Safety endpoint: Count of the number of AEs for each level of intensity: mild, moderate, or severe

Outcome measures

Measure	Auxora Cohort 1 n=7 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 2 n=3 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 3 n=3 Participants Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion).	Placebo n=1 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.	Placebo n=2 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.
Intensity of AEs Mild	13 Adverse Events	2 Adverse Events	9 Adverse Events	2 Adverse Events	5 Adverse Events
Intensity of AEs Moderate	21 Adverse Events	11 Adverse Events	8 Adverse Events	2 Adverse Events	7 Adverse Events
Intensity of AEs Severe	8 Adverse Events	2 Adverse Events	6 Adverse Events	0 Adverse Events	2 Adverse Events

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization up to 144 hours after SFISD (start of first infusion of study drug)

Safety endpoint: Patients experiencing Changes in cardiac conduction, defined as: QTcF interval of ≥ 500 msec; QTcF prolongation of ≥ 60 msec as compared to baseline; Mobitz Type II second degree atrioventricular (AV) block; Third degree or high grade AV block; or Polymorphic Ventricular Tachycardia

Outcome measures

Measure	Auxora Cohort 1 n=7 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 2 n=3 Participants Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 3 n=3 Participants Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion).	Placebo n=1 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.	Placebo n=2 Participants Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.
Number of Patients Experiencing Pre-defined Changes in Cardiac Conduction Assessed by ECG	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Auxora (ALL)

Serious events: 4 serious events

Other events: 7 other events

Deaths: 4 deaths

Auxora Cohort 1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Auxora Cohort 2

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Auxora Cohort 3

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	Auxora (ALL) n=7 participants at risk Combined Total data for Auxora-treated patients from all 3 Cohorts.	Auxora Cohort 1 n=3 participants at risk Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 2 n=3 participants at risk Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 3 n=1 participants at risk Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion).	Placebo n=2 participants at risk Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.
Cardiac disorders Pulseless electrical activity	14.3% 1/7 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Gastrointestinal disorders Gastrointestinal hemorrhage	14.3% 1/7 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Metabolism and nutrition disorders Acidosis	0.00% 0/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	50.0% 1/2 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Renal and urinary disorders Acute Kidney Injury	14.3% 1/7 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Respiratory, thoracic and mediastinal disorders Hypoxia	28.6% 2/7 • Number of events 2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	50.0% 1/2 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	50.0% 1/2 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Vascular disorders Septic shock	14.3% 1/7 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Vascular disorders Distributive shock	14.3% 1/7 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)

Other adverse events

Measure	Auxora (ALL) n=7 participants at risk Combined Total data for Auxora-treated patients from all 3 Cohorts.	Auxora Cohort 1 n=3 participants at risk Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 2 n=3 participants at risk Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours	Auxora Cohort 3 n=1 participants at risk Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion).	Placebo n=2 participants at risk Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours.
Blood and lymphatic system disorders Eosinophilia	14.3% 1/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Cardiac disorders Arrhythmia	14.3% 1/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Number of events 1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Hepatobiliary disorders Hypertransaminasemia	57.1% 4/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	66.7% 2/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	100.0% 1/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	50.0% 1/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Infections and infestations Systemic candida	14.3% 1/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Infections and infestations Enterococcal infection	0.00% 0/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	50.0% 1/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Infections and infestations Oral candidiasis	14.3% 1/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Infections and infestations Staphylococcal bacteremia	0.00% 0/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	50.0% 1/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Injury, poisoning and procedural complications Wound	0.00% 0/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	50.0% 1/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Investigations Blood creatine phosphokinase increased	14.3% 1/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	100.0% 2/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Metabolism and nutrition disorders Hypertriglyceridemia	14.3% 1/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	100.0% 1/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Psychiatric disorders Delirium	14.3% 1/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	100.0% 1/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Renal and urinary disorders Cystitis escherichia	14.3% 1/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Renal and urinary disorders Urinary retention	14.3% 1/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Respiratory, thoracic and mediastinal disorders Bronchopulmonary aspergillosis	14.3% 1/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Respiratory, thoracic and mediastinal disorders Enterobacter pneumonia	57.1% 4/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	100.0% 3/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Respiratory, thoracic and mediastinal disorders Lung abscess	0.00% 0/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	50.0% 1/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	57.1% 4/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	66.7% 2/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	66.7% 2/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Respiratory, thoracic and mediastinal disorders Pneumonia	14.3% 1/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Respiratory, thoracic and mediastinal disorders Pneumonia pseudomonal	14.3% 1/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Respiratory, thoracic and mediastinal disorders Pneumonia staphylococcal	28.6% 2/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	100.0% 1/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	50.0% 1/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Respiratory, thoracic and mediastinal disorders Pneumonia streptococcal	28.6% 2/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Respiratory, thoracic and mediastinal disorders Pneumothorax	28.6% 2/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	50.0% 1/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Vascular disorders Venous thrombosis	42.9% 3/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	66.7% 2/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	50.0% 1/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
Vascular disorders Superficial vein thrombosis	14.3% 1/7 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	33.3% 1/3 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/1 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)	0.00% 0/2 • Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60. Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)

Additional Information

Sudarshan Hebbar, MD (Chief Medical Officer)

CalciMedica

Phone: (816) 838-7105

Email: sudarshan@calcimedica.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI shall submit copies of the proposed results communications to the Sponsor at least 30 days in advance of the submission of any proposed publication to a journal, editor, or other third party. Sponsor may request that Confidential Information (other than Study Data) be removed from communications, or that the PI refrain from publication for an additional 60 days in order for patent application(s) directed to the patentable subject matter to be filed with the appropriate patent office(s).
• Publication restrictions are in place

Restriction type: OTHER